Devices and methods for gastrointestinal bypass

ABSTRACT

Devices and methods for gastrointestinal bypass are described. A gastrointestinal bypass device includes a gastrointestinal cuff and a gastrointestinal sleeve. The cuff may be configured to be attached in the esophagus, and may be sufficiently flexible to expand and collapse to conform with the inside of the esophagus to allow the esophagus to function substantially normally. The sleeve is configured to be coupled to the cuff, and may be made of a material that is floppy or flaccid but does not substantially expand radially.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/896,838, filed May 17, 2013, which is a continuation-in-partof U.S. patent application Ser. Nos. 13/743,285 and 13/743,287, bothfiled on Jan. 16, 2013, which are continuations-in-part of U.S. patentapplication Ser. Nos. 13/485,887, 13/485,889, 13/485,893, 13/485,896,and 13/485,898, all filed on May 31, 2012. The applications listed aboveare hereby incorporated by reference in their entireties.

BACKGROUND

Diabetes, heart disease, and other obesity-related conditions may betreated surgically with bariatric procedures such as jejuno-ilealbypass, jejuno-colic bypass, biliopancreatic diversion, gastric bypass,and gastroplasty. These procedures may be effective for weight controland treatment of chronic conditions. However, these procedures carrywith them substantial shortcomings, including the risk of infection andother risks accompanying surgery. Some of these procedures induceradical permanent changes to the gastrointestinal anatomy, thusforeclosing subsequent surgical intervention.

What is needed are devices and methods that use non-surgical techniquesthat avoid the risks associated with gastrointestinal bypass surgery.What is also needed are devices and methods for gastrointestinal bypassthat allow for additional or revision procedures to be performed. Whatis also needed are devices and methods for gastrointestinal bypass thatare reversible.

SUMMARY

A gastrointestinal bypass device is described. In one embodiment, thedevice may comprise a gastrointestinal cuff configured to be at leastpartially positioned in an esophagus. The device may also comprise agastrointestinal sleeve coupled to the cuff. The sleeve may beconfigured to be at least partially positioned in a stomach and a smallintestine. The cuff may be configured to allow a nonbypassed portion offood to pass into the stomach.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C show one embodiment of a gastrointestinal bypass device1000. FIG. 1D shows an enlarged view of a strut 1150.

FIGS. 2A-2C show another embodiment of a gastrointestinal bypass device2000. FIG. 2D shows an enlarged view of a hook 2160.

FIGS. 3A-3C show yet another embodiment of a gastrointestinal bypassdevice 3000. FIG. 3D shows still another embodiment of agastrointestinal bypass device 3000A. FIGS. 3E-3F show top views of cuff3100 in an open and a closed position. FIGS. 3G-3H show enlarged viewsof strut 3150. FIGS. 3I-3J show side views of cuff 3100 normally andsubjected to a retrograde force. FIGS. 3K-3L show other embodiments ofsleeve 3200.

FIGS. 3M-3O show additional embodiments of cuff 3100. FIGS. 3P-3Q showadditional embodiments of cuff 3100. FIGS. 3R-3S show additionalembodiments of sleeve 3200.

FIGS. 4A-4B show one embodiment of a tissue anchor 1300.

FIGS. 4C-4D show another embodiment of a tissue anchor 1300A.

FIGS. 4E-4G show one embodiment of a method for delivering tissue anchor1300.

FIGS. 5A-5C show one embodiment of a tissue marking device 1400.

FIGS. 6A-6D show one embodiment of a method for using tissue markingdevice 1400.

FIG. 7A shows one embodiment of a tissue marking device 2400.

FIGS. 7B-7D show various embodiments of marking surface 2420. FIG. 7Eshows various embodiments of openings 2426.

FIGS. 8A-8F show one embodiment of a method for using tissue markingdevice 2400.

FIGS. 9A-9C show one embodiment of a sleeve delivery device 1500.

FIGS. 9D-9G show one embodiment of a method for loading sleeve deliverydevice 1500.

FIGS. 10A-10C show another embodiment of a sleeve delivery device 2500.

FIGS. 10D-10G show one embodiment of a method for loading sleevedelivery device 2500.

FIGS. 11A-11C show yet another embodiment of a sleeve delivery device3500.

FIGS. 11D-11G show one embodiment of a method for loading sleevedelivery device 3500.

FIGS. 12A-12C show one embodiment of an anchor delivery device 1600.

FIGS. 13A-13E show one embodiment of a method for using anchor deliverydevice 1600.

FIGS. 14A-14C show one embodiment of a stent 1690.

FIGS. 15A-15G show another embodiment of an anchor delivery device 2600.

FIGS. 16A-16F show one embodiment of a method for using anchor deliverydevice 2600.

FIGS. 17A-17H show one embodiment of a method for implanting agastrointestinal bypass device 1000.

FIGS. 18A-18J show one embodiment of a method for implanting agastrointestinal bypass device 3000.

FIGS. 19A-19H show one embodiment of a method for exchanging a sleeve2200 of a gastrointestinal bypass device 2000.

FIG. 20A shows one embodiment of gastrointestinal cuff with one or moreattachment openings 3160 and a gastrointestinal sleeve with one or moreattachment elements 3260. FIGS. 20B-20E show various embodiments ofattachment openings 3160. FIGS. 20E-20G, 20H-20I, and 20J-20K showvarious embodiments of an attachment element 3260.

FIGS. 21A-21F show one embodiment of a method for using attachmentelement 3260 to attach a device through an attachment opening 3160formed in a wall.

FIGS. 22A-22D show another embodiment of a tissue anchor 2300.

FIGS. 22E-22G show one embodiment of a method for delivering tissueanchor 2300.

FIGS. 22H-22J show tissue anchor 2300 with various embodiments of atissue ingrowth element 2360.

FIGS. 23A-23C show another embodiment of a tissue anchor 3300.

FIGS. 24A-24D show another embodiment of a tissue anchor 4300.

FIGS. 24E-24G show one embodiment of a method for delivering tissueanchor 4300.

FIGS. 24H-24K show tissue anchor 4300 with various embodiments of atissue ingrowth element 4360.

FIGS. 25A-25D show various embodiments of cuff positions which may beused with the devices and methods described above. Tissue anchors may beused at the cuff positions to retain a gastrointestinal bypass device.

DESCRIPTION

FIGS. 1A-1C show one embodiment of a gastrointestinal bypass device1000. FIG. 1A shows a perspective view of gastrointestinal bypass device1000. FIG. 1B shows an exploded view of gastrointestinal bypass device1000.

FIG. 1C shows a cross-sectional view of gastrointestinal bypass device1000. FIG. 1D shows an enlarged view of a strut 1150.

Gastrointestinal bypass device 1000 may include a gastrointestinal cuff1100 and a gastrointestinal sleeve 1200.

Cuff 1100 may be configured to be positioned at least partially in theesophagus. Cuff 1100 may be positioned at or near the gastroesophagealjunction. Alternatively, cuff 1100 may be positioned proximal to thegastroesophageal junction, in the proximal stomach, or at some otherlocation. For example, cuff 1100 may be positioned within about 3 cm,2.5 cm, 2 cm, 1.5 cm, 1 cm, 0.5 cm, above, below, or at the GEJ orsquamocolumnar junction (SCJ or Z-line). As another example, cuff 1100may be positioned up to 5 cm above the diaphragm. Some non-limitinglocations for cuff 1100 can be found, for example, in U.S. Pat. Pub. No.2007/0198174 to Dann et al., which is hereby incorporated by referencein its entirety (e.g., at paras. [0131] to [0147]). Cuff 1100 may besufficiently flexible to expand and collapse to conform with the insideof the esophagus. Cuff 1100 also provides a structure to which sleeve1200 may be attached. Cuff 1100 may be positioned using tissue anchorsand/or an intragastric support such as that found, for example, in U.S.Pat. No. 8,182,441 to Swain et al.

Cuff 1100 may be configured to receive at least a portion of ingestedfood and allow this portion to pass inside cuff 1100 and into sleeve1200. This is a bypassed portion of food, or a portion of the ingestedfood that is bypassed past the stomach and into the small intestine.Cuff 1100 may be configured to allow a portion of ingested food to passinto the stomach. This is a nonbypassed portion of food, or a portion ofthe ingested food that is not bypassed past the stomach, but allowed toreach the stomach.

Cuff 1100 may include a liner 1110, a plurality of anchor holes 1130,and a plurality of struts 1150.

Liner 1110 may include a proximal portion 1111, a distal portion 1112, alumen 1113, and a longitudinal axis 1114. Liner 1110 may be tubular andmay have a uniform width. Alternatively, liner 1110 may taper or changein width. Liner 1110 may be made of material that is flexible. Thisflexibility allows the cuff position, such as the lower esophagealsphincter, to open and close substantially normally. Liner 1110 may bemade of a material that is thin, allowing it to collapse into a smallerprofile. This smaller profile allows the cuff position, such as thelower esophageal sphincter, to close substantially normally, and alsohelps liner 1110 to be collapsed for delivery. Liner 1110 may include asingle layer of material. Alternatively, liner 1110 may include aplurality of layers. In one embodiment, liner 1110 may have a length ofapproximately 20 mm to 80 mm. Liner 1110 may include a sleeve-couplingelement, e.g., suture holes 1115 formed at distal portion 1112.

Liner 1110 may be configured to allow a nonbypassed portion of food topass into the stomach. Allowing some food to reach the stomach may helpthe stomach to maintain at least some functionality. Allowing some foodto reach the stomach may also reduce the likelihood of nutrientdeficiency, as seen in some patients whose stomachs have been surgicallybypassed. In addition, oral medications may be allowed to reach thestomach.

Liner 1110 may be made of a material that is at least semi-permeable toingested food, including liquids and/or solids. Liner 1110 may be madeof a woven material, a mesh material, DACRON, and/or any other suitablematerial. The material may be selected to have pores or openings whichallow a desired amount of food to pass from the inside of liner 1110 tothe outside of liner 1110.

Alternatively, or in combination, liner 1110 may include nonbypassfeatures 1119 which allow a desired amount of food to pass from theinside of liner 1110 to the outside of liner 1110. Nonbypass features1119 may include one or more, or any combination of one or more,openings, slits, holes, channels, valves, flaps, and/or other suitablefeatures.

Nonbypass features 1119 may be configured to allow the amount of thenonbypassed portion of food to be adjusted in situ to provide adjustableor titratable bypass. For example, nonbypass features 1119 may includetemporary or removable panels which increase the number of holes oropenings in liner 1110. As another example, nonbypass features 1119 mayinclude temporary or removable layers which change the permeability ofliner 1110 to ingested food.

A coupling mechanism, e.g., anchor holes 1130 may be formed at or nearproximal portion 1111 of liner 1110. Anchor holes 1130 are configured toreceive tissue anchors. Anchor holes 1130 may be marked with acontrasting color, radiopaque marker, or other means to aidvisualization. Anchor holes 1130 may be marked with stitching, ink, orother suitable marking. Anchor holes 1130 may be used as a placementtemplate for tissue anchors. Anchor holes 1130 may be evenly spacedabout a circumference of liner 1110. Evenly spaced anchor holes 1130 mayhelp to distribute forces among the tissue anchors, preventconcentration of forces in a small number of tissue anchors, and enhanceconformance of liner 1110 to an inside (e.g., luminal wall) of theesophagus. Alternatively, anchor holes 1130 may be spaced in any mannerabout a circumference of liner 1110. Anchor holes 1130 may besubstantially coplanar. Anchor holes 1130 may be arranged in a planesubstantially perpendicular to longitudinal axis 1114, or angled tolongitudinal axis 1114. A substantially coplanar arrangement may help toprevent concentration of forces in a small number of tissue anchors.Alternatively, anchor holes 1130 may be arranged in a staggered fashion.

Struts 1150 each include a proximal portion 1151 and a distal portion1152. Struts 1150 may be elongate and substantially straight.Alternatively, struts 1150 may be curved or any other suitable shape.Struts 1150 may be coupled to an inner surface of liner 1110.Alternatively, struts 1150 may be coupled to an outer surface of liner1110 or between layers of liner 1110 to reduce obstructions on an innersurface of liner 1110. Struts 1150 may be coupled to liner 1110longitudinally. Alternatively, struts 1150 may be coupled to liner 1110at an angle of 1 to 30 degrees or more with respect to longitudinal axis1114 of liner 1110. Struts 1150 may include a first attachment element,e.g., an anchor hole 1154 at or near proximal portion 1151. Anchor holes1154 of struts 1150 may be aligned with anchor holes 1130 of liner 1110.Anchor holes 1154 of struts 1150 may reinforce anchor holes 1130 ofliner 1110 and prevent tissue anchors from pulling through. Struts 1150may include a second attachment element, .e.g., suture holes 1155, andstruts 1150 may be coupled to liner 1110 with sutures stitched throughsuture holes 1155 and liner 1110. Alternatively, struts 1150 may becoupled to liner 1110 with adhesives, thermal bonding, ultrasonic orlaser welding, pockets formed between layers of liner 1110, or othersuitable ways. Struts 1150 may have a uniform cross-section.Alternatively, struts 1150 may have a non-uniform cross-section whichvaries wider, narrower, thicker, and/or thinner. For example, struts1150 may each have a proximal portion 1151 and/or a distal portion 1152which are thinner. This thinner cross-section allows proximal portion1151 and/or distal portion 1152 to be more flexible. Struts 1150 may bemade of a plastic such as PEEK, a metal, or any other suitable material.

Struts 1150 may reduce longitudinal stretching of liner 1110. Progradeforces such as peristaltic forces at distal portion 1112 of liner 1110are transferred by struts 1150 to anchor holes 1154 and tissue anchors,to advantageously redistribute forces and minimize focal wear or failurepoints. Struts 1150 may also prevent inversion of liner 1110. Retrogradeforces such as vomiting or retching forces at distal portion 1112 ofliner 1110 are resisted by struts 1150, helping to maintain liner 1110in proper implanted position.

Sleeve 1200 may be configured to be positioned at least partially in thestomach and the small intestine. Sleeve 1200 is configured to be coupledto cuff 1100, either in an integrally formed or removably coupledmanner. Sleeve 1200 directs food and liquids into the intestine. Sleeve1200 may include a coupling 1210 and a tube 1250.

Coupling 1210 directs food and liquids from cuff 1100 to tube 1250.Coupling 1210 includes a proximal portion 1211, a distal portion 1212,and a lumen 1213. A coupling element, e.g., suture holes 1215 may beformed at or near proximal portion 1211 to allow coupling 1210 becoupled with sutures to a complementary cuff-coupling element, e.g.,suture holes 1115 in liner 1110. Proximal portion 1211 may have a widththat is the same or substantially the same as liner 1110, or in someembodiments taper down in width to restrict the flow of food and liquidsthrough coupling 1210, which may help to create a feeling of fullness.Distal portion 1212 may have a uniform width. Alternatively, proximalportion 1211 and distal portion 1212 may have a uniform width. Coupling1210 may be made of a material that is flexible, but does not stretchsubstantially in a radial or longitudinal direction. Coupling 1210 maybe made of a polyurethane elastomer such as PELLETHANE, or any othersuitable material.

Tube 1250 includes a proximal portion 1251, a distal portion 1252, and alumen 1253. Proximal portion 1251 of tube 1250 may be coupled to distalportion 1212 of coupling 1210 with an interference fit, heat bonded,and/or other suitable methods. Alternatively, tube 1250 may be formedintegrally with coupling 1210. Tube 1250 may have a uniform width.Alternatively, tube 1250 may taper or change in width. Tube 1250 mayallow food and liquids to bypass the stomach and/or part of theintestine. Tube 1250 may allow foods and liquids to be bypassed into theduodenum, jejunum, or other part of the intestine. In one embodiment,tube 1250 may have a length of approximately 80 cm to 450 cm, a diameterof approximately 15 mm to 25 mm, and/or a thickness of about 0.05 mm toabout 0.5 mm, such as about 0.15 mm.

Tube 1250 may be made of a material that is floppy or flaccid, but doesnot stretch substantially in a radial direction. Thus, tube 1250 may beflexible and compliant inwardly to allow peristaltic forces to act onits contents, but will not balloon outwardly. Tube 1250 may also notstretch substantially in a longitudinal direction. Tube 1250 may be madeof a polymer, polyethylene, polypropylene, polyurethane elastomer suchas PELLETHANE, or any other suitable material. Tube 1250 may beimpermeable or semi-permeable. Tube 1250 may allow nutrients andmedications inside tube 1250 to pass outward. Alternatively or inaddition, tube 1250 may allow digestive juices and hormones outside tube1250 to pass inward. Tube 1250 or portions of tube 1250 may bebiodegradable. Tube 1250 with a plurality of biodegradable portions maybe configured such that each portion degrades at a different rate.

Tube 1250 may include one or more coatings to resist calcification,deliver medications, provide lubriciousness, and/or provide otherdesired properties. These coatings may include parylene,polyvinylpyrrolidone (PVP), and/or other suitable materials. Tube 1250may include an electrical stimulation element to resist calcificationand promote motility and satiety. Various electrical stimulationelements that can be utilized or modified for use with the systems andmethods disclosed herein are described, for example, in U.S. Pat. No.7,881,797 to Griffin et al., which is hereby incorporated by referencein its entirety. Tube 1250 may be made up of one or more sections whichmay be coupled or uncoupled to adjust a length of tube 1250. Tube 1250may include one, two, or more additional lumens interior to, exteriorto, or within walls of tube 1250 for delivery of medications, access forimaging devices for visual monitoring, and access for diagnosticsampling. Tube 1250 may have additional lumens which open at differentpoints along the length of tube 1250 for targeted delivery or access.

Tube 1250 may include a radiopaque marker 1254. Radiopaque marker 1254may be one or more longitudinal stripes which run along all or part ofthe length of tube 1250. Radiopaque marker 1254 may be configured tohelp prevent or reduce kinking and twisting of tube 1250. For example,radiopaque marker 1254 may be thicker and/or wider toward proximalportion 1251 of tube 1250, where kinking and twisting may be morepronounced. Alternatively, radiopaque marker 1254 may be a helicalstripe, circumferential bands, or other suitable configuration.Radiopaque marker 1254 may be coupled to an inside surface of tube 1250to help maintain at least some patency of lumen 1253 and prevent lumen1253 from closing completely when tube 1250 is kinked or twisted.Alternatively, radiopaque marker 1254 may be coupled to an outsidesurface of tube 1250. Various embodiments, features, materials andparameters of cuffs, sleeves, anchors, and other components that can beused or modified for use with those disclosed herein are described, forexample, in the following patents and publications, each of which areincorporated by reference in their entireties: U.S. Pat. Pub. No.2007/0198074 to Dann et al., U.S. Pat. No. 8,070,743 to Kagan et al.,U.S. Pat. Pub. No. 2009/0149871 to Kagan et al., U.S. Pat. Pub. No.2004/0092892 to Kagan et al., U.S. Pat. Pub. No. 2006/0155375 to Kaganet al., U.S. Pat. Pub. No. 2006/0015125 to Swain, U.S. Pat. Pub. No.2006/0020254 to von Hoffmann, U.S. Pat. No. 8,118,774 to Dann et al.,U.S. Pat. Pub. No. 2009/0012553 to Swain et al., U.S. Pat. Pub. No.2009/0012544 to Thompson et al., and U.S. Pat. Pub. No. 2009/0012541 toDahl et al.

Tube 1250 may include one, two, three, or more tails 1255 at distalportion 1252. Tails 1255 may be folded over each other and cinched witha grasping element, such as a loop snare, to seal distal portion 1255 oftube 1250 during deployment of sleeve 1200. Tails 1255 may be asdescribed, for example, in U.S. Pat. No. 8,118,774 to Dann et al., whichis hereby incorporated by reference in its entirety.

Coupling 1210 and/or tube 1250 may be configured to allow a nonbypassedportion of food to pass into the stomach. Coupling 1210 and/or tube 1250may include nonbypass features 1259 which allow a desired amount of foodto pass from the inside of coupling 1210 and/or tube 1250 to the outsideof coupling 1210 and/or tube 1250. Nonbypass features 1259 may includeone or more, or any combination of one or more, openings, slits, holes,channels, valves, flaps, and/or other suitable features. These may belocated in the portion of tube 1250 that is positioned in the stomach,such as at or near proximal portion 1251 of tube 1250.

Nonbypass features 1259 may be configured to allow the amount of thenonbypassed portion of food to be adjusted in situ to provide adjustableor titratable bypass. For example, nonbypass features 1259 may includetemporary or removable panels which increase the number of holes oropenings in coupling 1210 and/or tube 1250. As another example,nonbypass features 1259 may include temporary or removable layers whichchange the permeability of coupling 1210 and/or tube 1250 to ingestedfood.

FIGS. 2A-2C show another embodiment of a gastrointestinal bypass device2000. FIG. 2A shows a perspective view of gastrointestinal bypass device2000. FIG. 2B shows an exploded view of gastrointestinal bypass device2000.

FIG. 2C shows a cross-sectional view of gastrointestinal bypass device2000. FIG. 2D shows an enlarged view of a hook 2160.

Gastrointestinal bypass device 2000 may include a gastrointestinal cuff2100 and a gastrointestinal sleeve 2200.

Cuff 2100 may be configured to be positioned at least partially in theesophagus. Cuff 2100 may be positioned at or near the gastroesophagealjunction. Alternatively, cuff 2100 may be positioned proximal to thegastroesophageal junction, in the proximal stomach, or at some otherlocation. For example, cuff 2100 may be positioned within about 3 cm,2.5 cm, 2 cm, 1.5 cm, 1 cm, 0.5 cm, above, below, or at the GEJ orsquamocolumnar junction (SCJ or Z-line). As another example, cuff 1100may be positioned up to 5 cm above the diaphragm. Some non-limitinglocations for cuff 2100 can be found, for example, in U.S. Pat. Pub. No.2007/0198174 to Dann et al., which is hereby incorporated by referencein its entirety (e.g., at paras. [0131] to [0147]). Cuff 2100 may besufficiently flexible to expand and collapse to conform with the insideof the esophagus. Cuff 2100 also provides a structure to which sleeve2200 may be attached. Cuff 2100 may be positioned using tissue anchorsand/or an intragastric support such as that found, for example, in U.S.Pat. No. 8,182,441 to Swain et al.

Cuff 2100 may be configured to receive at least a portion of ingestedfood and allow this portion to pass inside cuff 2100 and into sleeve2200. This is a bypassed portion of food, or a portion of the ingestedfood that is bypassed past the stomach and into the small intestine.Cuff 2100 may be configured to allow a portion of ingested food to passinto the stomach. This is a nonbypassed portion of food, or a portion ofthe ingested food that is not bypassed past the stomach, but allowed toreach the stomach.

Cuff 2100 may include a liner 2110, a plurality of anchor holes 2130, aretainer 2140, a plurality of struts 2150, and one or more hooks 2160.

Liner 2110 may include a proximal portion 2111, a distal portion 2112, alumen 2113, and a longitudinal axis 2114. Liner 2110 may be tubular andmay have a uniform width. Alternatively, liner 2110 may taper or changein width. Liner 2110 may be made of material that is flexible. Thisflexibility allows the cuff position, such as the lower esophagealsphincter, to open and close substantially normally. Liner 2110 may bemade of a material that is thin, allowing it to collapse into a smallerprofile. This smaller profile allows the cuff position, such as thelower esophageal sphincter, to close substantially normally, and alsohelps liner 2110 to be collapsed for delivery. Liner 2110 may include asingle layer of material. Alternatively, liner 2110 may include aplurality of layers. In one embodiment, liner 2110 may have a length ofapproximately 20 mm to 80 mm.

Liner 2110 may be configured to allow a nonbypassed portion of food topass into the stomach. Allowing some food to reach the stomach may helpthe stomach to maintain at least some functionality. Allowing some foodto reach the stomach may also reduce the likelihood of nutrientdeficiency, as seen in some patients whose stomachs have been surgicallybypassed. In addition, oral medications may be allowed to reach thestomach.

Liner 2110 may be made of a material that is at least semi-permeable toingested food, including liquids and/or solids. Liner 2110 may be madeof a woven material, a mesh material, DACRON, and/or any other suitablematerial. The material may be selected to have pores or openings whichallow a desired amount of food to pass from the inside of liner 2110 tothe outside of liner 2110.

Alternatively, or in combination, liner 2110 may include nonbypassfeatures 2119 which allow a desired amount of food to pass from theinside of liner 2110 to the outside of liner 2110. Nonbypass features2119 may include one or more, or any combination of one or more,openings, slits, holes, channels, valves, flaps, and/or other suitablefeatures.

Nonbypass features 2119 may be configured to allow the amount of thenonbypassed portion of food to be adjusted in situ to provide adjustableor titratable bypass. For example, nonbypass features 2119 may includetemporary or removable panels which increase the number of holes oropenings in liner 2110. As another example, nonbypass features 2119 mayinclude temporary or removable layers which change the permeability ofliner 2110 to ingested food.

A coupling mechanism, e.g. anchor holes 2130 may be formed at or nearproximal portion 2111 of liner 2110. Anchor holes 2130 are configured toreceive tissue anchors. Anchor holes 2130 may be marked with acontrasting color, radiopaque marker, or other means to aidvisualization. Anchor holes 2130 may be marked with stitching, ink, orother suitable marking Anchor holes 2130 may be used as a placementtemplate for tissue anchors. Anchor holes 2130 may be evenly spacedabout a circumference of liner 2110. Evenly spaced anchor holes 2130 mayhelp to distribute forces among the tissue anchors, preventconcentration of forces in a small number of tissue anchors, and enhanceconformance of liner 2110 to an inside (e.g., luminal wall) of theesophagus. Alternatively, anchor holes 2130 may be spaced in any mannerabout a circumference of liner 2110. Anchor holes 2130 may besubstantially coplanar. Anchor holes 2130 may be arranged in a planesubstantially perpendicular to longitudinal axis 2114, or angled tolongitudinal axis 2114. A substantially coplanar arrangement may help toprevent concentration of forces in a small number of tissue anchors.Alternatively, anchor holes 2130 may be arranged in a staggered fashion.

Retainer 2140 may be coupled to distal portion 2112 of liner 2110.Retainer 2140 may be collapsible radially inwardly but not expandableradially outwardly. Retainer 2140 may be a circumferential channelformed in distal portion 2112 of liner 2110 by one or more folds 2141.Folds 2141 may be secured by a suture 2142, adhesive, or other means.Folds 2141 may be made more rigid by applying a stiffening substance todistal portion 2112 and/or folds 2141. The stiffening substance may besilicone or other suitable substance. Alternatively, retainer 2140 maybe made of plastic or other suitable material, and coupled to distalportion 2112 of liner 2110.

Struts 2150 each include a proximal portion 2151 and a distal portion2152. Struts 2150 may be elongate and substantially straight.Alternatively, struts 2150 may be curved or any other suitable shape.Struts 2150 may be coupled to an inner surface of liner 2110.Alternatively, struts 2150 may be coupled to an outer surface of liner2110 or between layers of liner 2110 to reduce obstructions on an innersurface of liner 2110. Struts 2150 may be coupled to liner 2110longitudinally. Alternatively, struts 2150 may be coupled to liner 2110at an angle of 1 to 30 degrees or more with respect to longitudinal axis2114 of liner 2110. Struts 2150 may include a first attachment element,e.g., an anchor hole 2154 at or near proximal portion 2151. Anchor holes2154 of struts 2150 may be aligned with anchor holes 2130 of liner 2110.Anchor holes 2154 of struts 2150 may reinforce anchor holes 2130 ofliner 2110 and prevent tissue anchors from pulling through. Struts 2150may include a second attachment element, e.g., suture holes 2155, andstruts 2150 may be coupled to liner 2110 with sutures stitched throughsuture holes 2155 and liner 2110. Alternatively, struts 2150 may becoupled to liner 2110 with adhesives, thermal bonding, ultrasonic orlaser welding, pockets formed between layers of liner 2110, or othersuitable ways. Struts 2150 may have a uniform cross-section.Alternatively, struts 2150 may have a non-uniform cross-section whichvaries wider, narrower, thicker, and/or thinner. For example, struts2150 may each have a proximal portion 2151 and/or a distal portion 2152which are thinner. This thinner cross-section allows proximal portion2151 and/or distal portion 2152 to be more flexible. Struts 2150 may bemade of a plastic such as PEEK, a metal, or any other suitable material.

Struts 2150 may reduce longitudinal stretching of liner 2110. Progradeforces such as peristaltic forces at distal portion 2112 of liner 2110are transferred by struts 2150 to anchor holes 2154 and tissue anchors,to advantageously redistribute forces and minimize focal wear or failurepoints. Struts 2150 may also prevent inversion of liner 2110. Retrogradeforces such as vomiting or retching forces at distal portion 2112 ofliner 2110 are resisted by struts 2150, helping to maintain liner 2110in proper implanted position.

Hooks 2160 may each include a proximal portion 2161 and a distal portion2162. Proximal portion 2161 may be coupled to distal portion 2152 ofstrut 2150. Hooks 2160 may include one or more suture holes 2164 forstitching to liner 2110 and/or distal portion 2152 of strut 2150.Alternatively, hooks 2160 may be coupled to liner 2110 or one or morestruts 2150 with an adhesive or other suitable methods. Alternatively,hooks 2160 may be formed as part of one or more struts 2150. Hooks 2160may each include a retainer 2165 and a barb 2166. Distal portions 2162may be configured so that they do not substantially protrude beyondstruts 2150 into an interior of liner 2110. Distal portion 2112 of liner2110 may be enlarged in diameter or otherwise configured to accommodatehooks 2160.

Sleeve 2200 may be configured to be positioned at least partially in thestomach and the small intestine. Sleeve 2200 is configured to be coupledto cuff 2100, either in an integrally formed or removably coupledmanner. Sleeve 2200 directs food and liquids into the intestine. Sleeve2200 may include a coupling 2210, a ring 2240, a tube 2250, and a halo2260.

Coupling 2210 directs food and liquids from cuff 2100 to tube 2250.Coupling 2210 includes a proximal portion 2211, a distal portion 2212,and a lumen 2213. Drawstring holes 2215 may be formed at or nearproximal portion 2211. Proximal portion 2211 may have a width that isthe same or substantially the same as liner 2110, or in some embodimentstaper down in width to restrict the flow of food and liquids throughcoupling 2210, which may help to create a feeling of fullness. Distalportion 2212 may have a uniform width. Alternatively, proximal portion2211 and distal portion 2212 may have a uniform width. Coupling 2210 maybe made of a material that is flexible, but does not stretchsubstantially in a radial or longitudinal direction. Coupling 2210 maybe made of a polyurethane elastomer such as PELLETHANE, or any othersuitable material.

Ring 2240 may be coupled to proximal portion 2211 of coupling 2210. Ring2240 may be a thickened portion of coupling 2210, or a separatestructure operably attached to coupling 2210. Ring 2240 may besufficiently flexible to deform inwardly, but sufficiently rigid tospring back to its original shape. Ring 2240 is configured to interfacewith retainer 2140. Ring 2240 may have an interference fit with retainer2140, or other form of attachment. Sleeve 2200 is thus coupled to cuff2100 by ring 2240 and retainer 2140. Ring 2240 may deform when sleeve2200 is pulled distally to allow sleeve 2200 some travel, provide someshock absorption, and more evenly distribute forces to tissue anchors.Sleeve 2200 can be exchanged for a new, second sleeve having the same orone, two, or more differing properties by inwardly deforming ring 2240and removing sleeve 2200. Ring 2240 may be inwardly deformed using adrawstring 2241 threaded through drawstring holes 2215. Other propertiesof sleeves, cuffs, cuff-sleeve attachment interfaces, and sleeveexchange methods can be found, for example, in U.S. Pat. Pub. No.2007/0198074 to Dann et al., and U.S. Pat. No. 8,070,743 to Kagan etal., each of which are hereby incorporated by reference in theirentireties.

Tube 2250 includes a proximal portion 2251, a distal portion 2252, and alumen 2253. Proximal portion 2251 of tube 2250 may be coupled to distalportion 2212 of coupling 2210 with an interference fit, heat bonded,and/or other suitable methods. Alternatively, tube 2250 may be formedintegrally with coupling 2210. Tube 2250 may have a uniform width.Alternatively, tube 2250 may taper or change in width. Tube 2250 mayallow food and liquids to bypass the stomach and/or part of theintestine. Tube 2250 may allow foods and liquids to be bypassed into theduodenum, jejunum, or other part of the intestine. In one embodiment,tube 2250 may have a length of approximately 80 cm to 450 cm, a diameterof approximately 15 mm to 25 mm, and/or a thickness of about 0.05 mm toabout 0.5 mm, such as about 0.15 mm.

Tube 2250 may be made of a material that is floppy or flaccid, but doesnot stretch substantially in a radial direction. Thus, tube 2250 may beflexible and compliant inwardly to allow peristaltic forces to act onits contents, but will not balloon outwardly. Tube 2250 may also notstretch substantially in a longitudinal direction. Tube 2250 may be madeof a polymer, polyethylene, polypropylene, polyurethane elastomer suchas PELLETHANE, or any other suitable material. Tube 2250 may beimpermeable or semi-permeable. Tube 2250 may allow nutrients andmedications inside tube 2250 to pass outward. Alternatively or inaddition, tube 2250 may allow digestive juices and hormones outside tube2250 to pass inward. Tube 2250 or portions of tube 2250 may bebiodegradable. Tube 2250 with a plurality of biodegradable portions maybe configured such that each portion degrades at a different rate.

Tube 2250 may include one or more coatings to resist calcification,deliver medications, provide lubriciousness, and/or provide otherdesired properties. These coatings may include parylene,polyvinylpyrrolidone (PVP), and/or other suitable materials. Tube 2250may include an electrical stimulation element to resist calcificationand promote motility and satiety. Various electrical stimulationelements that can be utilized or modified for use with the systems andmethods disclosed herein are described, for example, in U.S. Pat. No.7,881,797 to Griffin et al., which is hereby incorporated by referencein its entirety. Tube 2250 may be made up of one or more sections whichmay be coupled or uncoupled to adjust a length of tube 2250. Tube 2250may include one, two, or more additional lumens interior to, exteriorto, or within walls of tube 2250 for delivery of medications, access forimaging devices for visual monitoring, and access for diagnosticsampling. Tube 2250 may have additional lumens which open at differentpoints along the length of tube 2250 for targeted delivery or access.

Tube 2250 may include a radiopaque marker 2254. Radiopaque marker 2254may be one or more longitudinal stripes which run along all or part ofthe length of tube 2250. Radiopaque marker 2254 may be configured tohelp prevent or reduce kinking and twisting of tube 2250. For example,radiopaque marker 2254 may be thicker and/or wider toward proximalportion 2251 of tube 2250, where kinking and twisting may be morepronounced. Alternatively, radiopaque marker 2254 may be a helicalstripe, circumferential bands, or other suitable configuration.Radiopaque marker 2254 may be coupled to an inside surface of tube 2250to help maintain at least some patency of lumen 2253 and prevent lumen2253 from closing completely when tube 2250 is kinked or twisted.Alternatively, radiopaque marker 2254 may be coupled to an outsidesurface of tube 2250. Various embodiments, features, materials andparameters of cuffs, sleeves, anchors, and other components that can beused or modified for use with those disclosed herein are described, forexample, in the following patents and publications, each of which areincorporated by reference in their entireties: U.S. Pat. Pub. No.2007/0198074 to Dann et al., U.S. Pat. No. 8,070,743 to Kagan et al.,U.S. Pat. Pub. No. 2009/0149871 to Kagan et al., U.S. Pat. Pub. No.2004/0092892 to Kagan et al., U.S. Pat. Pub. No. 2006/0155375 to Kaganet al., U.S. Pat. Pub. No. 2006/0015125 to Swain, U.S. Pat. Pub. No.2006/0020254 to von Hoffmann, U.S. Pat. No. 8,118,774 to Dann et al.,U.S. Pat. Pub. No. 2009/0012553 to Swain et al., U.S. Pat. Pub. No.2009/0012544 to Thompson et al., and U.S. Pat. Pub. No. 2009/0012541 toDahl et al.

Tube 2250 may include one, two, three, or more tails 2255 at distalportion 2252. Tails 2255 may be folded over each other and cinched witha grasping element, such as a loop snare, to seal distal portion 2255 oftube 2250 during deployment of sleeve 2200. Tails 2255 may be asdescribed, for example, in U.S. Pat. No. 8,118,774 to Dann et al., whichis hereby incorporated by reference in its entirety.

Coupling 2210 and/or tube 2250 may be configured to allow a nonbypassedportion of food to pass into the stomach. Coupling 2210 and/or tube 2250may include nonbypass features 2259 which allow a desired amount of foodto pass from the inside of coupling 2210 and/or tube 2250 to the outsideof coupling 2210 and/or tube 2250. Nonbypass features 2259 may includeone or more, or any combination of one or more, openings, slits, holes,channels, valves, flaps, and/or other suitable features. These may belocated in the portion of tube 2250 that is positioned in the stomach,such as at or near proximal portion 2251 of tube 2250.

Nonbypass features 2259 may be configured to allow the amount of thenonbypassed portion of food to be adjusted in situ to provide adjustableor titratable bypass. For example, nonbypass features 2259 may includetemporary or removable panels which increase the number of holes oropenings in coupling 2210 and/or tube 2250. As another example,nonbypass features 2259 may include temporary or removable layers whichchange the permeability of coupling 2210 and/or tube 2250 to ingestedfood.

Halo 2260 may be coupled to proximal portion 2211 of coupling 2210 byone or more standoffs 2261. Standoffs 2261 may be coupled to proximalportion 2211 of coupling 2210 using an adhesive or other suitablemethods. Halo 2260 may be made of suture or other suitable material.Halo 2260 is configured to be coupled to hooks 2160. Halo 2260 and hooks2160 may provide a primary or backup coupling between sleeve 2200 andcuff 2100. Halo 2260 and hooks 2160 are configured to keep sleeve 2200coupled to cuff 2100 if the coupling between retainer 2140 and ring 2240should fail. Halo 2260 may be cut between standoffs 2261 to releasesleeve 2200 for removal or exchange. Distal portion 2112 of liner 2110may be enlarged in diameter or otherwise configured to accommodate halo2260 and standoffs 2261.

FIGS. 3A-3C show yet another embodiment of a gastrointestinal bypassdevice 3000. FIG. 3A shows a perspective view of gastrointestinal bypassdevice 3000. FIG. 3B shows an exploded view of gastrointestinal bypassdevice 3000. FIG. 3C shows a cross-sectional view of gastrointestinalbypass device 3000. FIG. 3D shows still another embodiment of agastrointestinal bypass device 3000A. FIGS. 3E-3F show top views of cuff3100 in an open and a closed position. FIGS. 3G-3H show enlarged viewsof strut 3150. FIGS. 3I-3J show side views of cuff 3100 normally andsubjected to a retrograde force. FIGS. 3K-3L show other embodiments ofsleeve 3200.

Gastrointestinal bypass device 3000 may include a gastrointestinal cuff3100 and a gastrointestinal sleeve 3200.

Cuff 3100 may be configured to be positioned at least partially in theesophagus. Cuff 3100 may be positioned at or near the gastroesophagealjunction. Alternatively, cuff 3100 may be positioned proximal to thegastroesophageal junction, in the proximal stomach, or at some otherlocation. For example, cuff 3100 may be positioned within about 3 cm,2.5 cm, 2 cm, 1.5 cm, 1 cm, 0.5 cm, above, below, or at the GEJ orsquamocolumnar junction (SCJ or Z-line). As another example, cuff 1100may be positioned up to 5 cm above the diaphragm. Some non-limitinglocations for cuff 3100 can be found, for example, in U.S. Pat. Pub. No.2007/0198174 to Dann et al., which is hereby incorporated by referencein its entirety (e.g., at paras. [0131] to [0147]). Cuff 3100 may besufficiently flexible to expand and collapse to conform with the insideof the esophagus. Cuff 3100 also provides a structure to which sleeve3200 may be attached. Cuff 3100 may be positioned using tissue anchorsand/or an intragastric support such as that found, for example, in U.S.Pat. No. 8,182,441 to Swain et al.

Cuff 3100 may be configured to receive at least a portion of ingestedfood and allow this portion to pass inside cuff 3100 and into sleeve3200. This is a bypassed portion of food, or a portion of the ingestedfood that is bypassed past the stomach and into the small intestine.Cuff 3100 may be configured to allow a portion of ingested food to passinto the stomach. This is a nonbypassed portion of food, or a portion ofthe ingested food that is not bypassed past the stomach, but allowed toreach the stomach.

Cuff 3100 may include a liner 3110, an edge with one, two, or moreprojections, e.g., a scalloped edge 3120, a plurality of anchor holes3130, a retainer 3140, a plurality of struts 3150, one or moreattachment openings 3160, and a scaffold 3170.

Liner 3110 may include a proximal portion 3111, a distal portion 3112, alumen 3113, and a longitudinal axis 3114. Liner 3110 may be tubular andmay have a uniform width. Alternatively, liner 3110 may taper or changein width. Liner 3110 may be made of material that is flexible. Thisflexibility allows the cuff position, such as the lower esophagealsphincter, to open and close substantially normally. Liner 3110 may bemade of a material that is thin, allowing it to collapse into a smallerprofile. This smaller profile allows the cuff position, such as thelower esophageal sphincter, to close substantially normally, and alsohelps liner 3110 to be collapsed for delivery. Liner 3110 may include aninner layer 3116 and an outer layer 3117. Alternatively, liner 3110 mayinclude a single layer of material, or any number of layers. Inner layer3116 and outer layer 3117 may be sealed at proximal portion 3111 with anedge seal 3118. Edge seal 3118 may be silicone or other suitablematerial. Edge seal 3118 may be radiopaque. Alternatively, inner layer3116 and outer layer 3117 may be formed from a single layer of materialfolded over Inner layer 3116 and outer layer 3117 may be at leastpartially coupled together by sutures, thermal bonding, ultrasonic orlaser welding, or other ways. In one embodiment, liner 3110 may have alength of approximately 20 mm to 80 mm.

Liner 3110 may be configured to allow a nonbypassed portion of food topass into the stomach. Allowing some food to reach the stomach may helpthe stomach to maintain at least some functionality. Allowing some foodto reach the stomach may also reduce the likelihood of nutrientdeficiency, as seen in some patients whose stomachs have been surgicallybypassed. In addition, oral medications may be allowed to reach thestomach.

Liner 3110 may be made of a material that is at least semi-permeable toingested food, including liquids and/or solids. Liner 3110 may be madeof a woven material, a mesh material, DACRON, and/or any other suitablematerial. The material may be selected to have pores or openings whichallow a desired amount of food to pass from the inside of liner 3110 tothe outside of liner 3110, as shown in FIG. 3M.

Alternatively, or in combination, liner 3110 may include nonbypassfeatures 3119 which allow a desired amount of food to pass from theinside of liner 3110 to the outside of liner 3110, such as shown inFIGS. 3N-3O. Nonbypass features 3119 may include one or more, or anycombination of one or more, openings, slits, holes, channels, valves,flaps, and/or other suitable features.

Nonbypass features 3119 may be configured to allow the amount of thenonbypassed portion of food to be adjusted in situ to provide adjustableor titratable bypass. For example, nonbypass features 3119 may includetemporary or removable panels which increase the number of holes oropenings in liner 3110. As another example, nonbypass features 3119 mayinclude temporary or removable layers which change the permeability ofliner 3110 to ingested food.

Scalloped edge 3120 may include a plurality of peaks 3121 and valleys3122 formed at the edge of proximal portion 3111 of liner 3110. Peaks3121 and valleys 3122 may be of uniform shape and size. Alternatively,peaks 3121 and valleys 3122 may be of varying shapes and sizes.Scalloped edge 3120 allows peaks 3121 to open wider than the rest ofliner 3110, as shown in FIG. 3E.

The shape and size of peaks 3121 and valleys 3122 may be selected toenhance conformance of scalloped edge 3120 to an inside of the esophagusand reduce the amount of ingested food which passes outside of scallopededge 3120 and into the stomach (and thus outside of cuff 3100 and sleeve3200). Valleys 3122 may include a webbing which may be thinner thanliner 3110. Scalloped edge 3120 reduces bunching of liner 3110 when theesophagus is closed, and reduces the profile of liner 3110 when theesophagus is closed, as shown in FIG. 3F.

Alternatively, the shape and size of peaks 3121 and valleys 3122 may beselected to allow a nonbypassed portion of food to pass through valleys3122 to an outside of liner 3110 and into the stomach. For example,peaks 3121 may be taller and valleys 3122 be deeper to allow a largeramount of nonbypassed portion of food to pass through valleys 3122 andinto the stomach, as shown in FIG. 3P. As another example, peaks 3121and valleys 3122 may be flat, resulting in a proximal portion 3111 ofliner 3110 with a straight edge, as shown in FIG. 3Q.

A coupling mechanism, e.g., anchor holes 3130 may be formed in the peaks3121 of scalloped edge 3120. Anchor holes 3130 are configured to receivetissue anchors. Anchor holes 3130 may be marked with a contrastingcolor, radiopaque marker, or other means to aid visualization. Anchorholes 3130 may be marked with stitching, ink, or other suitable markingAnchor holes 3130 may be used as a placement template for tissueanchors. Anchor holes 3130 may be evenly spaced about a circumference ofliner 3110. Evenly spaced anchor holes 3130 may help to distributeforces among the tissue anchors, prevent concentration of forces in asmall number of tissue anchors, and enhance conformance of liner 3110 toan inside (e.g., luminal wall) of the esophagus. Alternatively, anchorholes 3130 may be spaced in any manner about a circumference of liner3110. Anchor holes 3130 may be substantially coplanar. Anchor holes 3130may be arranged in a plane substantially perpendicular to longitudinalaxis 3114, or angled to longitudinal axis 3114. A substantially coplanararrangement may help to prevent concentration of forces in a smallnumber of tissue anchors. Alternatively, anchor holes 3130 may bearranged in a staggered fashion.

Retainer 3140 may be coupled to distal portion 3112 of liner 3110.Retainer 3140 may be collapsible radially inwardly but not expandableradially outwardly. Retainer 3140 may be a circumferential channelformed in distal portion 3112 of liner 3110 by one or more folds 3141.Folds 3141 may be secured by a suture 3142, adhesive, or other means.Folds 3141 may be made more rigid by applying a stiffening substance todistal portion 3112 and/or folds 3141. The stiffening substance may besilicone or other suitable substance. Alternatively, retainer 3140 maybe made of plastic or other suitable material, and coupled to distalportion 3112 of liner 3110.

Struts 3150 each include a proximal portion 3151 and a distal portion3152. Struts 3150 may be elongate and substantially straight.Alternatively, struts 3150 may be curved or any other suitable shape.Struts 3150 may be coupled to liner 3110 between layers of liner 3110.Alternatively, struts 3150 may be coupled to an inner surface or anouter surface of liner 3110. Struts 3150 may be coupled to liner 3110 atan angle of 1 to 30 degrees or more with respect to longitudinal axis3114 of liner 3110. Alternatively, struts 3150 may be coupled to liner3110 longitudinally without an angle. Struts 3150 may include a firstattachment element, e.g., an anchor eyelet 3154 at proximal portion3151. Struts 3150 may include a second attachment element, e.g., asuture eyelet 3155 at distal portion 3152. Anchor eyelets 3154 may bealigned with anchor holes 3130 of liner 3110 to reinforce anchor holes3130 of liner 3110 and prevent tissue anchors from pulling through.Struts 3150 may be coupled to liner 3110 with pockets formed bystitching together layers of liner 3110, and stitching through sutureeyelets 3155. Alternatively, struts 3150 may be coupled to liner 3110with sutures, adhesives, thermal bonding, ultrasonic or laser welding,or other suitable ways. Struts 3150 may have a uniform cross-section.Alternatively, struts 3150 may have a non-uniform cross-section whichvaries wider, narrower, thicker, and/or thinner. For example, struts3150 may have a proximal portion 3151 and/or a distal portion 3152 whichare thinner and/or wider, as shown in FIGS. 3G-3H. This varyingcross-section allows proximal portion 3151 and/or distal portion 3152 tobe more flexible. Struts 3150 may include a notch 3157. Struts 3150 maybe made of a plastic such as PEEK, a metal, or any other suitablematerial.

Struts 3150 may reduce longitudinal stretching of liner 3110. Progradeforces such as peristaltic forces at distal portion 3112 of liner 3110are transferred by struts 3150 to anchor eyelets 3154 and tissueanchors, to advantageously redistribute forces and minimize focal wearor failure points. Struts 3150 may also prevent inversion of liner 3110.Retrograde forces such as vomiting or retching forces at distal portion3112 of liner 3110 cause liner 3110 and angled struts 3150 to twist orcorkscrew about longitudinal axis 3114 and prevents inversion of liner3110, as shown in FIGS. 3I-3J, helping to maintain liner 3110 in properimplanted position. This twisting or corkscrewing may also at leastpartially close lumen 3113 of liner 3110.

Attachment openings 3160 may be formed at distal portion 3112 of liner3110. Attachment openings 3160 may be marked with a contrasting color toaid visualization. Attachment openings 3160 may be marked withstitching, ink, or other suitable marking.

Scaffold 3170 may be coupled to liner 3110 between layers of liner.Alternatively, scaffold may be coupled to an inner surface or an outersurface of liner 3110. Scaffold 3170 may be coupled to liner 3110 withsutures, adhesives, or other suitable ways. Scaffold 3170 may have anydesired wall pattern, and in some embodiments resemble a sawtooth wave,sine wave, square wave, triangle wave, or other wave. Scaffold 3170 mayinclude a plurality of proximal segments 3171 and a plurality of distalsegments 3172 connected by a plurality of connecting segments 3173.Alternatively, scaffold 3170 may be a mesh, ring, or other suitabledevice. Scaffold 3170 may be coupled to struts 3150, or formedintegrally with struts 3150. Scaffold 3170 may cross each strut 3150through notch 3157.

Scaffold 3170 provides an outward bias to enhance conformance of liner3110 to the luminal wall of the esophagus. This outward bias may belarge enough to open liner 3110 when the esophagus opens, but not solarge as to prevent the esophagus from closing. Scaffold 3170 is notnecessarily meant to hold cuff 3100 in the esophagus. Scaffold 3170 mayhave a geometry, such as length and thickness, selected to create adesired amount of outward bias. Scaffold 3170 may be made of a materialselected to create a desired amount of outward bias. Scaffold 3170 maybe made of plastic such as PEEK, metal, or any other suitable material.Proximal segments 3171 may be placed at or near valleys 3122. Thisplacement positions outward bias at valleys 3122. Any portion ofscaffold 3170 may be placed across struts 3150. The placement ofscaffold 3170 across struts 3150 may be selected to create a desiredamount of outward bias. For example, distal segments 3172 may be placedacross struts 3150. This placement provides a pivot point for connectingsegments 3173 of scaffold 3170. This placement may also fold or rotatepeaks 3121 when liner 3110 closes, resulting in a smaller closedprofile, as shown in FIGS. 3E-3F.

Sleeve 3200 may be configured to be positioned at least partially in thestomach and the small intestine. Sleeve 3200 is configured to be coupledto cuff 3100, either in an integrally formed or removably coupledmanner. Sleeve 3200 directs food and liquids into the intestine. Sleeve3200 may include a coupling 3210, a ring 3240, a tube 3250, and one ormore attachment elements 3260.

Coupling 3210 directs food and liquids from cuff 3100 to tube 3250.Coupling 3210 includes a proximal portion 3211, a distal portion 3212,and a lumen 3213. Drawstring holes 3215 may be formed at or nearproximal portion 3211. Proximal portion 3211 may have a width that isthe same or substantially the same as liner 3110, or in some embodimentstaper down in width to restrict the flow of food and liquids throughcoupling 3210, which may help to create a feeling of fullness. Distalportion 3212 may have a uniform width. Alternatively, proximal portion3211 and distal portion 3212 may have a uniform width. Coupling 3210 maybe made of a material that is flexible, but does not stretchsubstantially in a radial or longitudinal direction. Coupling 3210 maybe made of a polyurethane elastomer such as PELLETHANE, or any othersuitable material.

Ring 3240 may be coupled to proximal portion 3211 of coupling 3210. Ring3240 may be a thickened portion of coupling 3210, or a separatestructure operably attached to coupling 3210. Ring 3240 may besufficiently flexible to deform inwardly, but sufficiently rigid tospring back to its original shape. Ring 3240 is configured to interfacewith retainer 3140. Ring 3240 may have an interference fit with retainer3140, or other form of attachment. Sleeve 3200 is thus coupled to cuff3100 by ring 3240 and retainer 3140. Ring 3240 may deform when sleeve3200 is pulled distally to allow sleeve 3200 some travel, provide someshock absorption, and more evenly distribute forces to tissue anchors.Sleeve 3200 can be exchanged for a new, second sleeve having the same orone, two, or more differing properties by inwardly deforming ring 3240and removing sleeve 3200. Ring 3240 may be inwardly deformed using adrawstring 3241 threaded through drawstring holes 3215. Other propertiesof sleeves, cuffs, cuff-sleeve attachment interfaces, and sleeveexchange methods can be found, for example, in U.S. Pat. Pub. No.2007/0198074 to Dann et al., and U.S. Pat. No. 8,070,743 to Kagan etal., each of which are hereby incorporated by reference in theirentireties.

Tube 3250 includes a proximal portion 3251, a distal portion 3252, and alumen 3253. Proximal portion 3251 of tube 3250 may be coupled to distalportion 3212 of coupling 3210 with an interference fit, heat bonded,and/or other suitable methods. Alternatively, tube 3250 may be formedintegrally with coupling 3210. Tube 3250 may have a uniform width.Alternatively, tube 3250 may taper or change in width. Tube 3250 mayallow food and liquids to bypass the stomach and/or part of theintestine. Tube 3250 may allow foods and liquids to be bypassed into theduodenum, jejunum, or other part of the intestine. In one embodiment,tube 3250 may have a length of approximately 80 cm to 450 cm, a diameterof approximately 15 mm to 25 mm, and/or a thickness of about 0.05 mm toabout 0.5 mm, such as about 0.15 mm.

Tube 3250 may be made of a material that is floppy or flaccid, but doesnot stretch substantially in a radial direction. Thus, tube 3250 may beflexible and compliant inwardly to allow peristaltic forces to act onits contents, but will not balloon outwardly. Tube 3250 may also notstretch substantially in a longitudinal direction. Tube 3250 may be madeof a polymer, polyethylene, polypropylene, polyurethane elastomer suchas PELLETHANE, or any other suitable material. Tube 3250 may beimpermeable or semi-permeable. Tube 3250 may allow nutrients andmedications inside tube 3250 to pass outward. Alternatively or inaddition, tube 3250 may allow digestive juices and hormones outside tube3250 to pass inward. Tube 3250 or portions of tube 3250 may bebiodegradable. Tube 3250 with a plurality of biodegradable portions maybe configured such that each portion degrades at a different rate.

Tube 3250 may include one or more coatings to resist calcification,deliver medications, provide lubriciousness, and/or provide otherdesired properties. These coatings may include parylene,polyvinylpyrrolidone (PVP), and/or other suitable materials. Tube 3250may include an electrical stimulation element to resist calcificationand promote motility and satiety. Various electrical stimulationelements that can be utilized or modified for use with the systems andmethods disclosed herein are described, for example, in U.S. Pat. No.7,881,797 to Griffin et al., which is hereby incorporated by referencein its entirety. Tube 3250 may be made up of one or more sections whichmay be coupled or uncoupled to adjust a length of tube 3250. Tube 3250may include one, two, or more additional lumens interior to, exteriorto, or within walls of tube 3250 for delivery of medications, access forimaging devices for visual monitoring, and access for diagnosticsampling. Tube 3250 may have additional lumens which open at differentpoints along the length of tube 3250 for targeted delivery or access.

Tube 3250 may include a radiopaque marker 3254. Radiopaque marker 3254may be one or more longitudinal stripes which run along all or part ofthe length of tube 3250. Radiopaque marker 3254 may be configured tohelp prevent or reduce kinking and twisting of tube 3250. For example,radiopaque marker 3254 may be thicker and/or wider toward proximalportion 3251 of tube 3250 as shown in FIG. 3K, where kinking andtwisting may be more pronounced. Alternatively, radiopaque marker 3254may be a helical stripe as shown in FIG. 3L, circumferential bands, orother suitable configuration. Radiopaque marker 3254 may be coupled toan inside surface of tube 3250 to help maintain at least some patency oflumen 3253 and prevent lumen 3253 from closing completely when tube 3250is kinked or twisted. Alternatively, radiopaque marker 3254 may becoupled to an outside surface of tube 3250. Various embodiments,features, materials and parameters of cuffs, sleeves, anchors, and othercomponents that can be used or modified for use with those disclosedherein are described, for example, in the following patents andpublications, each of which are incorporated by reference in theirentireties: U.S. Pat. Pub. No. 2007/0198074 to Dann et al., U.S. Pat.No. 8,070,743 to Kagan et al., U.S. Pat. Pub. No. 2009/0149871 to Kaganet al., U.S. Pat. Pub. No. 2004/0092892 to Kagan et al., U.S. Pat. Pub.No. 2006/0155375 to Kagan et al., U.S. Pat. Pub. No. 2006/0015125 toSwain, U.S. Pat. Pub. No. 2006/0020254 to von Hoffmann, U.S. Pat. No.8,118,774 to Dann et al., U.S. Pat. Pub. No. 2009/0012553 to Swain etal., U.S. Pat. Pub. No. 2009/0012544 to Thompson et al., and U.S. Pat.Pub. No. 2009/0012541 to Dahl et al.

Tube 3250 may include one, two, three, or more tails 3255 at distalportion 3252. Tails 3255 may be folded over each other and cinched witha grasping element, such as a loop snare, to seal distal portion 3255 oftube 3250 during deployment of sleeve 3200. Tails 3255 may be asdescribed, for example, in U.S. Pat. No. 8,118,774 to Dann et al., whichis hereby incorporated by reference in its entirety.

Coupling 3210 and/or tube 3250 may be configured to allow a nonbypassedportion of food to pass into the stomach. Coupling 3210 and/or tube 3250may include nonbypass features 3259 which allow a desired amount of foodto pass from the inside of coupling 3210 and/or tube 3250 to the outsideof coupling 3210 and/or tube 3250, as shown in FIGS. 3R-3S. Nonbypassfeatures 3259 may include one or more, or any combination of one ormore, openings, slits, holes, channels, valves, flaps, and/or othersuitable features. These may be located in the portion of tube 3250 thatis positioned in the stomach, such as at or near proximal portion 3251of tube 3250.

Nonbypass features 3259 may be configured to allow the amount of thenonbypassed portion of food to be adjusted in situ to provide adjustableor titratable bypass. For example, nonbypass features 3259 may includetemporary or removable panels which increase the number of holes oropenings in coupling 3210 and/or tube 3250. As another example,nonbypass features 3259 may include temporary or removable layers whichchange the permeability of coupling 3210 and/or tube 3250 to ingestedfood.

Attachment elements 3260 are configured to be coupled to attachmentopenings 3160. Attachment elements 3260 and attachment openings 3160 mayprovide a first, e.g., a primary, or second, e.g., a backup, couplingbetween sleeve 3200 and cuff 3100. Attachment elements 3260 andattachment openings 3160 may be configured to keep sleeve 3200 coupledto cuff 3100 if the coupling between retainer 3140 and ring 3240 shouldfail.

FIG. 20A shows one embodiment of cuff 3100 with one or more attachmentopenings 3160 and sleeve 3200 with one or more attachment elements 3260.FIGS. 20B-20E show various embodiments of attachment openings 3160.FIGS. 20E-20G, 20H-20I, and 20J-20K show enlarged and exploded views ofvarious embodiments of an attachment element 3260.

Attachment openings 3160 may be round, oval, or any other suitableshape. Attachment openings 3160 may be deformable or substantiallyrigid. Attachment openings 3160 may include one or more flaps 3161 thatcover attachment openings 3160 which are not in use to reduce leakagethrough attachment openings 3160. As shown in FIGS. 20B-20E, flaps 3161may be arranged in a t-, T-, X-, or slit-like configuration,respectively, or any other suitable configuration. Flaps 3161 may beflexible to allow attachment element 3260 to pass through. Flaps 3161may be made of a similar or different material as the rest of liner3110. For example, flaps 3161 may be made of silicone or other suitablematerial.

Attachment element 3260 may include an elongate member 3261, a tensionelement 3265, and at least one grasping aid 3268. The number ofattachment elements 3260 may be equal or unequal to the number ofattachment openings 3160. In other applications, attachment element 3260may be used to couple any device through an attachment opening 3160formed in a wall of a mating device or tissue wall by deployingattachment element 3260 on an opposite side of the wall.

Elongate member 3261 includes a central portion 3262. Elongate member3261 is configured to be passed longitudinally through attachmentopening 3160 from the inside of liner 3110, and deployed transversely onthe outside of liner 3110. Elongate member 3261 is of a length or otherphysical dimensions which will not be pulled through attachment opening3160 after being deployed. Elongate member 3261 may be straight, curved,or any other suitable shape. Elongate member 3261 may include one ormore holes 3263 through which tension element 3265 may be coupled.Elongate member 3261 may include one or more holes 3264 through whichgrasping aid 3268 may be coupled. One or more holes 3264 may be incommunication with one or more holes 3263, as shown in FIGS. 20E-20G and20H-20I. Elongate member 3261 may be at least partially radiopaque toaid in placement and monitoring.

Tension element 3265 includes a proximal portion 3266 and a distalportion 3267. Proximal portion 3266 may be coupled to sleeve 3200.Distal portion 3267 may be flexibly coupled to central portion 3262 ofelongate member 3261. Tension element 3265 may be a loop of suturepassed through holes 3263 in elongate member 3263 and holes in sleeve3200 and secured with one or more knots. Alternatively, tension element3265 may be made of a length of suture, or any other suitable material.Alternatively, tension element 3265 may be a tube, stick, or othersuitable element. Tension element 3265 may be substantially flexible orsubstantially rigid. Tension element 3265 may be stretchable to allowsleeve 3200 some travel, provide some shock absorption, and to moreevenly distribute forces to tissue anchors. Tension element 3265 may becut to release sleeve 3200 for removal or exchange.

Grasping aid 3268 may be grasped by a grasper, hook, or other suitabletool and advanced through attachment opening 3160 along with elongatemember 3261 and distal portion 3267 of tension element 3265. Attachmentopening 3160 may be sized or otherwise configured to allow the tool,elongate member 3261, and distal portion 3267 of tension element 3265 topass through together. Grasping aid 3268 may be coupled to or near atleast one end of elongate member 3261. Grasping aid 3268 may include aloop of suture or a length of suture. Alternatively, grasping aid 3268may include a substantially rigid extension or stub flexibly or rigidlycoupled to or near at least one end of elongate member 3261.

Tension element 3265 and grasping aid 3268 may be formed from acontinuous piece of suture or other material which passes through holes3263 and holes 3264 and is secured by one or more knots 3269, as shownin FIGS. 20E-20G and 20H-20I. Alternatively, tension element 3265 andgrasping aid 3268 may be include separate pieces of suture, or similaror dissimilar materials, as shown in FIGS. 20J-20K. Grasping aid 3268may be secured by one or more knots 3269.

FIGS. 21A-21F show one embodiment of a method for using attachmentelement 3260 to attach a device through an attachment opening 3160formed in a wall.

FIG. 21A shows advancing a tool, in this embodiment a grasper G, fromthe working channel of an endoscope E.

FIG. 21B shows using the grasper G to grasp grasping aid 3268.

FIG. 21C shows advancing the grasper G toward attachment opening 3160from the inside of liner 3110. Grasper G may include a working end thatis pre-curved and/or steerable to aid in manipulating elongate member3261 through attachment opening 3160.

FIG. 21D shows advancing the grasper G through attachment opening 3160to pass grasping aid 3268 through attachment opening 3160 from theinside of liner 3110. Because grasping aid 3268 is coupled to or near anend of elongate member 3261 and pulls on or near the end of elongatemember 3261, elongate member 3261 becomes aligned to pass longitudinallythrough attachment opening 3160. Because distal portion 3267 of tensionelement 3265 may be flexibly coupled to elongate member 3261, elongatemember 3261 may move or rotate with respect to tension element 3265.

FIG. 21E shows continuing to advance the grasper G through attachmentopening 3160 to pass elongate member 3261 longitudinally throughattachment opening 3160. Also passed through attachment opening 3160 arethe grasper G and the distal portion 3267 of tension element 3265.

FIG. 21F shows releasing grasping aid 3268 to deploy elongate member3261 transversely on the outside of liner 3110. Elongate member 3261 ispassed through attachment opening 3160 completely. Releasing graspingaid 3268 generally causes elongate member 3261 to catch or deploytransversely on the outside of liner 3110. If elongate member 3261passes back through attachment opening 3160, the grasper G may be usedto grasp grasping aid 3268 or other part of elongate member 3261 andattempt deployment again.

One or more safety sutures may be used to provide a backup couplingbetween sleeve 3200 and cuff 3100. Safety sutures may be cut to releasesleeve 3200 for removal or exchange.

FIGS. 4A-4B show one embodiment of a tissue anchor 1300.

FIG. 4A shows a perspective view of tissue anchor 1300. FIG. 4B shows across-sectional view of tissue anchor 1300.

FIGS. 4C-4D show another embodiment of a tissue anchor 1300A.

FIG. 4C shows a perspective view of tissue anchor 1300A. FIG. 4D shows across-sectional view of tissue anchor 1300A.

The cuffs and/or sleeves described above may be anchored, for example,using tissue anchors 1300 and tissue anchors 1300A, or any othersuitable tissue anchor. Other tissue anchors or features of tissueanchors that may be used with systems and methods as described hereincan be found, for example, in U.S. Pat. Pub. No. 2009/0012541 to Dahl etal., which is hereby incorporated by reference in its entirety.

Tissue anchor 1300 and tissue anchor 1300A are configured to passthrough a tissue wall to retain a device. For example, tissue anchor1300 and tissue anchor 1300A may be configured to pass through an anchorhole in a cuff and transmurally through the wall of the esophagus toretain a cuff in the esophagus.

Tissue anchor 1300 and tissue anchor 1300A each include a proximalretention element 1310, a distal retention element 1320, and a tensionelement 1350.

Proximal retention element 1310 is configured to be deployed on aproximal side of a tissue wall. Proximal retention element 1310 may be abutton, a bar, or other suitable shape. In one embodiment, proximalretention element 1310 may be a button having a diameter ofapproximately 2 mm to 5 mm, and a thickness of approximately 0.25 mm to1 mm. Proximal retention element 1310 may include one or more holes1311. Proximal retention element 1310 may be at least partiallyradiopaque to aid in placement and monitoring.

Distal retention element 1320 is configured to be deployed on a distalside of a tissue wall. Distal retention element 1320 may include a hub1330 and a plurality of petals 1340.

Hub 1330 includes a proximal end 1331, a distal end 1332, and alongitudinal axis 1333. Hub 1330 includes an inner tube 1334 having acentral lumen 1335. Hub 1330 also includes an outer tube 1336. Innertube 1334 and outer tube 1336 form an annular space 1337. Inner tube1334 and outer tube 1336 may be substantially the same length, or be ofdifferent lengths Inner tube 1334 and outer tube 1336 may be made of astainless steel or other suitable material.

Petals 1340 each include a proximal side 1341, a distal side 1342, anopen area 1344, a hub portion 1345, an inclined portion 1346, and atissue contact portion 1347. Hub portion 1345 is coupled to tissuecontact portion 1347 by inclined portion 1346. Hub portion 1345 is atleast partially positioned within annular space 1337. Hub portion 1345may be coupled to inner tube 1334 and outer tube 1336 with an adhesive1338, solder or weld joint, laser weld, compression fit, or othersuitable ways. Adhesive 1338 may be a two-part epoxy or other suitablematerial or adhesive. In one embodiment, hub portion 1345 may have alength of approximately 0.5 mm to 2 mm. Inclined portion 1346 extendsfrom proximal end 1331 of hub 1330. In one embodiment, inclined portion1346 may be inclined at an angle of approximately 30 to 60 degrees withrespect to longitudinal axis 1333. Alternatively, inclined portion 1346may be inclined at a variable angle between 0 and 90 degrees withrespect to longitudinal axis 1333. In one embodiment as shown in FIGS.4A-4B, inclined portion 1346 may have a length of approximately 3 mm to4 mm. In another embodiment as shown in FIGS. 4C-4D, inclined portion1346 may have a length of approximately 2 mm to 3 mm.

Tissue contact portion 1347 is configured to contact a distal surface ofa tissue wall. Tissue contact portion 1347 may be substantially flat, orit may be configured to curve away from the distal surface of a tissuewall. Tissue contact portion 1347 may be substantially perpendicular tolongitudinal axis 1333. Alternatively, tissue contact portion 1347 maybe slightly curved to conform to the distal surface of a tissue wall.Tissue contact portion 1347 may be proximal to proximal end 1331 of hub1330 to prevent hub 1330 from contacting the distal surface of a tissuewall. Tissue contact portion 1347 may have an open structure whichreduces the amount of material coming into contact with a distal surfaceof a tissue wall. This open structure may reduce a response by a tissuewall to tissue contact portion 1347. In one embodiment as shown in FIGS.4A-4B, tissue contact portion 1347 may have a footprint having anoutside diameter of approximately 7 mm to 8 mm, and an inside diameterof approximately 4 mm to 5 mm. In another embodiment as shown in FIGS.4C-4D, tissue contact portion 1347 may have a footprint having anoutside diameter of approximately 8 mm to 10 mm, and an inside diameterof approximately 4 mm to 5 mm.

Petals 1340 may be sufficiently flexible to be collapsed into a deliveryconfiguration for delivery inside a needle and expanded into a deployedconfiguration on a distal side of a tissue wall. Petals 1340 may besufficiently flexible to provide shock absorption. Petals 1340 may beformed of one or more loops or lengths of wire, cut from one or moresheets of material, or made using any other suitable method. In oneembodiment, petals 1340 may be formed of wire having a diameter ofapproximately 0.1 mm to 0.2 mm. Petals 1340 may be made of nitinol orother suitable material. Petals 1340 may be coated or treated with anantibiotic or other therapeutic agent.

In one embodiment, distal retention element 1320 may have a height ofapproximately 1 mm to 5 mm.

Tension element 1350 includes a proximal portion 1351 and a distalportion 1352. Proximal portion 1351 is coupled to proximal retentionelement 1310. Proximal portion 1351 may pass through hole 1311 ofproximal retention element 1310 and coupled with one or more knots.Distal portion 1352 is positioned within central lumen 1335 of innertube 1334. Distal portion 1352 may be coupled to inner tube 1334 with anadhesive 1339, solder or weld joint, laser weld, compression fit, orother suitable ways. Adhesive 1339 may be a two-part epoxy or othersuitable material or adhesive. Distal portion 1352 may also be coupledto inner tube 1334 with one or more knots. Tension element 1350 isconfigured to pass through a tissue wall. Tension element 1350 may havea reduced width or thickness in order to decrease the size of the holethrough a tissue wall, which may lower the likelihood of infection orother response. In one embodiment, tension element 1350 may have adiameter of approximately 0.2 mm to 0.5 mm. Tension element 1350 may beelastic or inelastic. Tension element 1350 may include a suture, wire,superelastic polymer, or other suitable material or device. Tensionelement 1350 may be coated or treated with an antibiotic agent.Alternatively, tension element 1350 may include an ultrathin coatedstent that is stretchable and presents no interstitial spaces tosurrounding tissue.

FIGS. 4E-4G show one embodiment of a method for delivering tissue anchor1300. For clarity, a pushrod is not shown. FIG. 4E shows tissue anchor1300 packaged inside a delivery needle N in a collapsed or deliveryconfiguration. FIG. 4F shows tissue anchor 1300 being pushed out of thedelivery needle N. FIG. 4G shows tissue anchor 1300 completely pushedout of delivery needle N and into an expanded or deployed configuration.

FIGS. 22A-22D show another embodiment of a tissue anchor 2300. FIG. 22Ashows a perspective view of tissue anchor 2300. FIG. 22B shows a bottomview of distal retention element 2320 of tissue anchor 2300. FIG. 22Cshows a side view of tissue anchor 2300. FIG. 22D shows across-sectional view of distal retention element 2320 of tissue anchor2300.

The cuffs and/or sleeves described above may be anchored, for example,using tissue anchors 2300 or any other suitable tissue anchor. Othertissue anchors or features of tissue anchors that may be used withsystems and methods as described herein can be found, for example, inU.S. Pat. Pub. No. 2009/0012541 to Dahl et al., which is herebyincorporated by reference in its entirety.

Tissue anchor 2300 is configured to pass through a tissue wall to retaina device. For example, tissue anchor 2300 may be configured to passthrough an anchor hole in a cuff and transmurally through the wall ofthe esophagus to retain a cuff in the esophagus.

Tissue anchor 2300 includes a proximal retention element 2310, a distalretention element 2320, and a tension element 2350.

Proximal retention element 2310 is configured to be deployed on aproximal side of a tissue wall. Proximal retention element 2310 may be abutton, a bar, or other suitable shape. In one embodiment, proximalretention element 2310 may be a button having a diameter ofapproximately 2 mm to 5 mm, and a thickness of approximately 0.25 mm to1 mm. Proximal retention element 2310 may include one or more holes2311. Proximal retention element 2310 may be at least partiallyradiopaque to aid in placement and monitoring.

Distal retention element 2320 is configured to be deployed on a distalside of a tissue wall. Distal retention element 2320 may include aproximal side 2321, a distal side 2322, a hub 2330, and a plurality ofpetals 2340.

Hub 2330 includes a proximal end 2331, a distal end 2332, and alongitudinal axis 2333. Hub 2330 includes an inner tube 2334 having acentral lumen 2335. Hub 2330 also includes an outer tube 2336. Innertube 2334 and outer tube 2336 form an annular space 2337. Inner tube2334 and outer tube 2336 may be substantially the same length, or be ofdifferent lengths Inner tube 2334 and outer tube 2336 may be made of astainless steel or other suitable material.

Petals 2340 each include a proximal side 2341, a distal side 2342, anopen area 2344, hub portion 2345, a connecting portion 2346, and atissue contact portion 2347. Hub portion 2345 is coupled to tissuecontact portion 2347 by connecting portion 2346. Hub portion 2345 is atleast partially positioned within annular space 2337. Hub portion 2345may be coupled to inner tube 2334 and outer tube 2336 with an adhesive2338, solder or weld joint, laser weld, compression fit, or othersuitable ways. Adhesive 2338 may be a two-part epoxy or other suitablematerial or adhesive. In one embodiment, hub portion 2345 may have alength of approximately 0.5 mm to 2 mm. Connecting portion 2346 extendsfrom distal end 2332 of hub 2330. Connecting portion 2346 may include afirst curved portion 2348 and a second curved portion 2349. First curvedportion 2348 may couple hub portion 2345 to connecting portion 2346.First curved portion 2348 may extend from distal end 2332 of hub 2330substantially parallel to longitudinal axis 2333, and curveapproximately 135 to 180 degrees away from longitudinal axis 2333.Second curved portion 2349 may couple connecting portion 2346 to tissuecontact portion 2347. Second curved portion 2349 may curve approximately45 to 90 degrees away from longitudinal axis 2333. Thus, tissue contactportion 2347 may extend outward away from longitudinal axis 2333.Connecting portion 2346 may have a length of approximately 3 mm to 5 mm.

Tissue contact portion 2347 is configured to contact a distal surface ofa tissue wall. Tissue contact portion 2347 may be substantially flat, orit may be configured to curve away from the distal surface of a tissuewall. Tissue contact portion 2347 may be substantially perpendicular tolongitudinal axis 2333. Alternatively, tissue contact portion 2347 maybe slightly curved to conform to the distal surface of a tissue wall.Tissue contact portion 2347 may be proximal to proximal end 2331 of hub2330 to prevent hub 2330 from contacting the distal surface of a tissuewall. Tissue contact portion 2347 may have an open structure whichreduces the amount of material coming into contact with a distal surfaceof a tissue wall. This open structure may reduce a response by a tissuewall to tissue contact portion 2347. In one embodiment, tissue contactportion 2347 may have a footprint having an outside diameter ofapproximately 7 mm to 8 mm, and an inside diameter of approximately 4 mmto 5 mm. In another embodiment, tissue contact portion 2347 may have afootprint having an outside diameter of approximately 8 mm to 10 mm, andan inside diameter of approximately 4 mm to 5 mm.

Petals 2340 may be sufficiently flexible to be collapsed into a deliveryconfiguration for delivery inside a needle and expanded into a deployedconfiguration on a distal side of a tissue wall. Petals 2340 may besufficiently flexible to provide shock absorption. Petals 2340 may beformed of one or more loops or lengths of wire, cut from one or moresheets of material, or made using any other suitable method. In oneembodiment, petals 2340 may be formed of wire having a diameter ofapproximately 0.1 mm to 0.2 mm. Petals 2340 may be made of nitinol orother suitable material. Petals 2340 may be coated or treated with anantibiotic or other therapeutic agent.

Petals 2340, especially first curved portions 2348 of connectingportions 2346, may form a distal side 2322 which is rounded orsubstantially flat, which may be less traumatic to surrounding tissue.Also, because petals 2340 extend from distal end 2332 of hub 2330, hub2330 may be positioned closer to the distal surface of a tissue wall anddistal retention element 2320 may have a reduced height, which maylessen the likelihood of tumbling or tipping over. In one embodiment,distal retention element 2320 may have a height of approximately 1 mm to5 mm.

Tension element 2350 includes a proximal portion 2351 and a distalportion 2352. Proximal portion 2351 is coupled to proximal retentionelement 2310. Proximal portion 2351 may pass through hole 2311 ofproximal retention element 2310 and coupled with one or more knots.Distal portion 2352 is positioned within central lumen 2335 of innertube 2334. Distal portion 2352 may be coupled to inner tube 2334 with anadhesive 2339, solder or weld joint, laser weld, compression fit, orother suitable ways. Adhesive 2339 may be a two-part epoxy or othersuitable material or adhesive. Distal portion 2352 may also be coupledto inner tube 2334 with one or more knots. Tension element 2350 isconfigured to pass through a tissue wall. Tension element 2350 may havea reduced width or thickness in order to decrease the size of the holethrough a tissue wall, which may lower the likelihood of infection orother response. In one embodiment, tension element 2350 may have adiameter of approximately 0.2 mm to 0.5 mm. Tension element 2350 may beelastic or inelastic. Tension element 2350 may include a suture, wire,superelastic polymer, or other suitable material or device. Tensionelement 2350 may be coated or treated with an antibiotic agent.Alternatively, tension element 2350 may include an ultrathin coatedstent that is stretchable and presents no interstitial spaces tosurrounding tissue.

FIGS. 22E-22G show one embodiment of a method for delivering tissueanchor 2300. FIG. 22E shows tissue anchor 2300 packaged inside adelivery needle N in a collapsed or delivery configuration. FIG. 22Fshows tissue anchor 2300 being pushed out of the delivery needle N. FIG.22G shows tissue anchor 2300 completely pushed out of delivery needle Nand into an expanded or deployed configuration. Because petals 2340extend from distal end 2332 of hub 2330, tissue anchor 2300 may beconfigured with a shorter tension element 2350 and may be deployed withless needle penetration.

FIGS. 22H-22J show tissue anchor 2300 with various embodiments of atissue ingrowth element 2360. Tissue ingrowth element 2360 may becoupled to distal retention element 2320. Tissue ingrowth element 2360may allow at least a portion of a tissue surrounding distal retentionelement 2320 to at least partially grow into and help secure distalretention element 2320. The tissue may include tissue in the vicinity ofor adjacent to a tissue wall. The tissue may include one or more layersof the tissue wall itself. Tissue ingrowth element 2360 may reducemigration or movement of tissue anchor 2300 after delivery.

FIG. 22H shows tissue anchor 2300 with one embodiment of a tissueingrowth element 2360. Tissue ingrowth element 2360 may include a cover2365. Cover 2365 may at least partially cover proximal side 2321 and/ordistal side 2322 of distal retention element 2320. Cover 2365 mayconform to distal retention element 2320. Alternatively, cover 2365 mayspan across proximal side 2321 of distal retention element 2320. Cover2365 may be stitched or otherwise coupled to itself or to petals 2340.Alternatively, cover 2365 may be configured to retain itself over distalretention element 2320. For example, cover 2365 may be sufficientlyelastic to fit over distal retention element 2320 and retain itself overdistal retention element 2320. Cover 2365 may be coupled to proximal end2331 and/or distal end 2332 of hub 2330, such as to inner tube 2334 ofhub 2330. Cover 2365 may be coupled to hub 2330 by melt welding, or anyother suitable method. Cover 2365 may be sufficiently compressibleand/or collapsible to allow distal retention element 2320 to collapsedinto and delivered with a delivery needle.

FIG. 22I shows tissue anchor 2300 with another embodiment of a tissueingrowth element 2360. Tissue ingrowth element 2360 may include one ormore covers 2366. Each cover 2366 may at least partially cover proximalside 2341 and/or distal side 2342 of a petal 2340. Covers 2366 may bestitched or otherwise coupled to themselves or to petals 2340.Alternatively, covers 2366 may be configured to retain themselves overpetals 2340. For example, covers 2366 may be sufficiently elastic to fitover petals 2340 and retain themselves over petals 2340. Covers 2366 maybe coupled to proximal end 2331 and/or distal end 2332 of hub 2330, suchas to inner tube 2334 of hub 2330. Covers 2366 may be coupled to hub2330 by melt welding, or any other suitable method. Covers 2366 may besufficiently compressible and/or collapsible to allow distal retentionelement 2320 to collapsed into and delivered with a delivery needle.

FIG. 22J shows tissue anchor 2300 with another embodiment of a tissueingrowth element 2360. Tissue ingrowth element 2360 may include awebbing 2367. Webbing 2367 may be formed at least partially in open area2344 of one or more petals 2340. Alternatively, or in addition, webbing2367 may be formed at least partially in one or more areas betweenpetals 2340. Webbing 2367 may be coupled to petals 2340 by melt welding,or any other suitable method. Webbing 2367 may be sufficientlycompressible and/or collapsible to allow distal retention element 2320to collapsed into and delivered with a delivery needle.

Tissue ingrowth element 2360 may be used with any suitable tissueanchor, such as a T-tag. Tissue ingrowth element 2360 may be used withany suitable distal retention element, such as those described in U.S.Pat. Nos. 8,070,743 and 8,182,459, and U.S. Patent ApplicationPublication 2009/0012541. Tissue ingrowth element 2360 may be used withany suitable frame or structure that is collapsible, compressible,and/or may be delivered inside a delivery needle.

Tissue ingrowth element 2360 may include a mesh made of fabric, plastic,metal, or any other suitable material. For example, tissue ingrowthelement 2360 may include a knitted or woven material made of a polyesteror polypropylene. Tissue ingrowth element 2360 may have a mesh size thatallows or promotes tissue ingrowth, such as a mesh size ranging fromabout 6 μm to about 2.5 mm. Tissue ingrowth element 2360 may also have amesh size large enough to permit macrophages to pass through, such as amesh size greater than about 80-100 μm.

FIGS. 23A-23C show another embodiment of a tissue anchor 3300. FIG. 23Ashows a perspective view of tissue anchor 3300. FIG. 23B shows a topview of tissue anchor 3300. FIG. 23C shows a side view of tissue anchor3300.

The cuffs and/or sleeves described above may be anchored, for example,using tissue anchors 3300 or any other suitable tissue anchor. Othertissue anchors or features of tissue anchors that may be used withsystems and methods as described herein can be found, for example, inU.S. Pat. Pub. No. 2009/0012541 to Dahl et al., which is herebyincorporated by reference in its entirety.

Tissue anchor 3300 is configured to pass through a tissue wall to retaina device. For example, tissue anchor 3300 may be configured to passthrough an anchor hole in a cuff and transmurally through the wall ofthe esophagus to retain a cuff in the esophagus.

Tissue anchor 3300 includes a proximal retention element 3310, a distalretention element 3320, and a tension element 3350.

Proximal retention element 3310 is configured to be deployed on aproximal side of a tissue wall. Proximal retention element 3310 may be abutton, a bar, or other suitable shape. In one embodiment, proximalretention element 3310 may be a button having a diameter ofapproximately 2 mm to 5 mm, and a thickness of approximately 0.25 mm to1 mm. Proximal retention element 3310 may include one or more holes3311. Proximal retention element 3310 may be at least partiallyradiopaque to aid in placement and monitoring.

Distal retention element 3320 is configured to be deployed on a distalside of a tissue wall. Distal retention element 3320 may include aproximal side 3321, a distal side 3322, a hub 3330, and a plurality ofpetals 3340.

Hub 3330 includes a proximal end 3331, a distal end 3332, and alongitudinal axis 3333.

Petals 3340 each include a proximal side 3341, a distal side 3342, anopen area 3344, a connecting portion 3346 and a tissue contact portion3347. Tissue contact portion 3347 is coupled to hub 3330 by connectingportion 3346. Connecting portion 3346 extends from distal end 3332 ofhub 3330. Connecting portion 3346 may include a first curved portion3348 and a second curved portion 3349. First curved portion 3348 maycouple hub 3330 to connecting portion 3346. First curved portion 3348may extend from distal end 3332 of hub 3330 substantially parallel tolongitudinal axis 3333, and curve approximately 135 to 180 degrees awayfrom longitudinal axis 3333. Second curved portion 3349 may coupleconnecting portion 3346 to tissue contact portion 3347. Second curvedportion 3349 may curve approximately 45 to 90 degrees away fromlongitudinal axis 3333. Thus, tissue contact portion 3347 may extendoutward away from longitudinal axis 3333. Connecting portion 3346 mayhave a length of approximately 3 mm to 5 mm.

Tissue contact portion 3347 is configured to contact a distal surface ofa tissue wall. Tissue contact portion 3347 may be substantially flat, orit may be configured to curve away from the distal surface of a tissuewall. Tissue contact portion 3347 may be substantially perpendicular tolongitudinal axis 3333. Alternatively, tissue contact portion 3347 maybe slightly curved to conform to the distal surface of a tissue wall.Tissue contact portion 3347 may be proximal to proximal end 3331 of hub3330 to prevent hub 3330 from contacting the distal surface of a tissuewall. Tissue contact portion 3347 may have an open structure whichreduces the amount of material coming into contact with a distal surfaceof a tissue wall. This open structure may reduce a response by a tissuewall to tissue contact portion 3347. In one embodiment, tissue contactportion 3347 may have a footprint having an outside diameter ofapproximately 7 mm to 8 mm, and an inside diameter of approximately 4 mmto 5 mm. In another embodiment, tissue contact portion 3347 may have afootprint having an outside diameter of approximately 8 mm to 10 mm, andan inside diameter of approximately 4 mm to 5 mm.

Petals 3340 may be sufficiently flexible to be collapsed into a deliveryconfiguration for delivery inside a needle and expanded into a deployedconfiguration on a distal side of a tissue wall. Petals 3340 may besufficiently flexible to provide shock absorption. Petals 2340 may beformed of one or more loops or lengths. Petals 2340 may have a thicknessof approximately 0.1 mm to 0.2 mm. Hub 3330 and petals 3340 may be lasercut, stamped, or otherwise manufactured from a single piece of material,such as a sheet or tube of material. Petals 3340 may be set into adesired shape by heat setting, cold working, or other suitable ways. Hub3330 and petals 3340 may be made of nitinol or other suitable material.Petals 3340 may be coated or treated with an antibiotic or othertherapeutic agent.

Petals 3340, especially first curved portions 3348 of connectingportions 3346, may form a distal side 3322 which is rounded orsubstantially flat, which may be less traumatic to surrounding tissue.Also, because petals 3340 extend from distal end 3332 of hub 3330, hub3330 may be positioned closer to the distal surface of a tissue wall anddistal retention element 3320 may have a reduced height, which maylessen the likelihood of tumbling or tipping over. In one embodiment,distal retention element 3320 may have a height of approximately 1 mm to5 mm.

Tension element 3350 includes a proximal portion 3351 and a distalportion 3352. Proximal portion 3351 is coupled to proximal retentionelement 3310. Proximal portion 3351 may pass through hole 3311 ofproximal retention element 3310 and coupled with one or more knots.Distal portion 3352 is positioned within central lumen 3335 of innertube 3334. Distal portion 3352 may be coupled to inner tube 3334 with anadhesive 3339, solder or weld joint, laser weld, compression fit, orother suitable ways. Adhesive 3339 may be a two-part epoxy or othersuitable material or adhesive. Distal portion 3352 may also be coupledto inner tube 3334 with one or more knots. Tension element 3350 isconfigured to pass through a tissue wall. Tension element 3350 may havea reduced width or thickness in order to decrease the size of the holethrough a tissue wall, which may lower the likelihood of infection orother response. In one embodiment, tension element 3350 may have adiameter of approximately 0.2 mm to 0.5 mm. Tension element 3350 may beelastic or inelastic. Tension element 3350 may include a suture, wire,superelastic polymer, or other suitable material or device. Tensionelement 3350 may be coated or treated with an antibiotic agent.Alternatively, tension element 3350 may include an ultrathin coatedstent that is stretchable and presents no interstitial spaces tosurrounding tissue.

FIGS. 24A-24D show another embodiment of a tissue anchor 4300. FIG. 24Ashows a perspective view of tissue anchor 4300. FIG. 24B shows a topview of distal retention element 4320 of tissue anchor 4300. FIG. 24Cshows a side view of tissue anchor 4300. FIG. 24D shows across-sectional view of tissue anchor 4300.

The cuffs and/or sleeves described above may be anchored, for example,using tissue anchors 4300 or any other suitable tissue anchor. Othertissue anchors or features of tissue anchors that may be used withsystems and methods as described herein can be found, for example, inU.S. Pat. Pub. No. 2009/0012541 to Dahl et al., which is herebyincorporated by reference in its entirety.

Tissue anchor 4300 is configured to pass through a tissue wall to retaina device. For example, tissue anchor 4300 may be configured to passthrough an anchor hole in a cuff and transmurally through the wall ofthe esophagus to retain a cuff in the esophagus.

Tissue anchor 4300 includes a proximal retention element 4310, a distalretention element 4320, and a tension element 4350.

Proximal retention element 4310 is configured to be deployed on aproximal side of a tissue wall. Proximal retention element 4310 may be abutton, a bar, or other suitable shape. In one embodiment, proximalretention element 4310 may be a button having a diameter ofapproximately 2 mm to 5 mm, and a thickness of approximately 0.25 mm to1 mm. Proximal retention element 4310 may include one or more holes4311. Proximal retention element 4310 may be at least partiallyradiopaque to aid in placement and monitoring.

Distal retention element 4320 is configured to be deployed on a distalside of a tissue wall. Distal retention element 4320 may include aproximal side 4321, a distal side 4322, a hub 4330, and a plurality ofpetals 4340.

Hub 4330 includes a proximal end 4331, a distal end 4332, and alongitudinal axis 4333. Hub 4330 includes an inner tube 4334 having acentral lumen 4335. Hub 4330 also includes an outer tube 4336. Innertube 4334 and outer tube 4336 form an annular space 4337. Inner tube4334 and outer tube 4336 may be substantially the same length, or be ofdifferent lengths Inner tube 4334 and outer tube 4336 may be made of astainless steel or other suitable material.

Petals 4340 each include a proximal side 4341, a distal side 4342, anopen area 4344, hub portion 4345, a connecting portion 4346, and atissue contact portion 4347. Hub portion 4345 is coupled to tissuecontact portion 4347 by connecting portion 4346. Hub portion 4345 is atleast partially positioned within annular space 4337. Hub portion 4345may be coupled to inner tube 4334 and outer tube 4336 with an adhesive4338, solder or weld joint, laser weld, compression fit, or othersuitable ways. Adhesive 4338 may be a two-part epoxy or other suitablematerial or adhesive. In one embodiment, hub portion 4345 may have alength of approximately 0.5 mm to 2 mm. Connecting portion 4346 extendsfrom distal end 4332 of hub 4330. Connecting portion 4346 may include afirst curved portion 4348 and a second curved portion 4349. First curvedportion 4348 may couple hub portion 4345 to connecting portion 4346.First curved portion 4348 may extend from distal end 4332 of hub 4330substantially parallel to longitudinal axis 4333, and curveapproximately 60 to 120 degrees away from longitudinal axis 4333. Secondcurved portion 4349 may couple connecting portion 4346 to tissue contactportion 4347. Second curved portion 4349 may curve approximately 150 to210 degrees proximally toward longitudinal axis 4333. Thus, tissuecontact portion 4347 may extend inward toward longitudinal axis 4333.Connecting portion 4346 may have a length of approximately 3 mm to 7 mm.

Tissue contact portion 4347 is configured to contact a distal surface ofa tissue wall. Tissue contact portion 4347 may be substantially flat, orit may be configured to curve away from the distal surface of a tissuewall. Tissue contact portion 4347 may be substantially perpendicular tolongitudinal axis 4333. Alternatively, tissue contact portion 4347 maybe slightly curved to conform to the distal surface of a tissue wall.Tissue contact portion 4347 may be proximal to proximal end 4331 of hub4330 to prevent hub 4330 from contacting the distal surface of a tissuewall. Tissue contact portion 4347 may have an open structure whichreduces the amount of material coming into contact with a distal surfaceof a tissue wall. This open structure may reduce a response by a tissuewall to tissue contact portion 4347. In one embodiment, tissue contactportion 4347 may have a footprint having an outside diameter ofapproximately 7 mm to 8 mm, and an inside diameter of approximately 4 mmto 5 mm. In another embodiment, tissue contact portion 4347 may have afootprint having an outside diameter of approximately 8 mm to 10 mm, andan inside diameter of approximately 4 mm to 5 mm.

Petals 4340 may be sufficiently flexible to be collapsed into a deliveryconfiguration for delivery inside a needle and expanded into a deployedconfiguration on a distal side of a tissue wall. Petals 4340 may besufficiently flexible to provide shock absorption. Petals 4340 may beformed of one or more loops or lengths of wire, cut from one or moresheets of material, or made using any other suitable method. In oneembodiment, petals 4340 may be formed of wire having a diameter ofapproximately 0.1 mm to 0.2 mm. Petals 4340 may be made of nitinol orother suitable material. Petals 4340 may be coated or treated with anantibiotic or other therapeutic agent.

Petals 4340, especially connecting portions 4346, may form a distal side4322 which is rounded or substantially flat, which may be less traumaticto surrounding tissue. Also, because petals 4340 extend from distal end4332 of hub 4330, hub 4330 may be positioned closer to the distalsurface of a tissue wall and distal retention element 4320 may have areduced height, which may lessen the likelihood of tumbling or tippingover. In one embodiment, distal retention element 4320 may have a heightof approximately 1 mm to 5 mm.

Tension element 4350 includes a proximal portion 4351 and a distalportion 4352. Proximal portion 4351 is coupled to proximal retentionelement 4310. Proximal portion 4351 may pass through hole 4311 ofproximal retention element 4310 and coupled with one or more knots.Distal portion 4352 is positioned within central lumen 4335 of innertube 4334. Distal portion 4352 may be coupled to inner tube 4334 with anadhesive 4339, solder or weld joint, laser weld, compression fit, orother suitable ways. Adhesive 4339 may be a two-part epoxy or othersuitable material or adhesive. Distal portion 4352 may also be coupledto inner tube 4334 with one or more knots. Tension element 4350 isconfigured to pass through a tissue wall. Tension element 4350 may havea reduced width or thickness in order to decrease the size of the holethrough a tissue wall, which may lower the likelihood of infection orother response. In one embodiment, tension element 4350 may have adiameter of approximately 0.2 mm to 0.5 mm. Tension element 4350 may beelastic or inelastic. Tension element 4350 may include a suture, wire,superelastic polymer, or other suitable material or device. Tensionelement 4350 may be coated or treated with an antibiotic agent.Alternatively, tension element 4350 may include an ultrathin coatedstent that is stretchable and presents no interstitial spaces tosurrounding tissue.

FIGS. 24E-24G show one embodiment of a method for delivering tissueanchor 4300. FIG. 24E shows tissue anchor 4300 packaged inside adelivery needle in a collapsed or delivery configuration. FIG. 24F showstissue anchor 4300 being pushed out of the delivery needle. FIG. 24Gshows tissue anchor 4300 completely pushed out of delivery needle andinto an expanded or deployed configuration. Because petals 4340 extendfrom distal end 4332 of hub 4330, tissue anchor 4300 may be configuredwith a shorter tension element 4350 and may be deployed with less needlepenetration.

FIGS. 24H-24K show tissue anchor 4300 with various embodiments of atissue ingrowth element 4360. Tissue ingrowth element 4360 may becoupled to distal retention element 4320. Tissue ingrowth element 4360may allow at least a portion of a tissue surrounding distal retentionelement 4320 to at least partially grow into and help secure distalretention element 4320. The tissue may include tissue in the vicinity ofor adjacent to a tissue wall. The tissue may include one or more layersof the tissue wall itself. Tissue ingrowth element 4360 may reducemigration or movement of tissue anchor 4300 after delivery.

FIGS. 24H-24I shows tissue anchor 4300 with one embodiment of a tissueingrowth element 4360. Tissue ingrowth element 4360 may include a cover4365. Cover 4365 may at least partially cover proximal side 4321 and/ordistal side 4322 of distal retention element 4320. Cover 4365 mayconform to distal retention element 4320, as can be seen in thecross-sectional view shown in FIG. 24I. Alternatively, cover 4365 mayspan across proximal side 4321 of distal retention element 4320. Cover4365 may be stitched or otherwise coupled to itself or to petals 4340.Alternatively, cover 4365 may be configured to retain itself over distalretention element 4320. For example, cover 4365 may be sufficientlyelastic to fit over distal retention element 4320 and retain itself overdistal retention element 4320. Cover 4365 may be coupled to proximal end4331 and/or distal end 4332 of hub 4330, such as to inner tube 4334 ofhub 4330. Cover 4365 may be coupled to hub 4330 by melt welding, or anyother suitable method. Cover 4365 may be sufficiently compressibleand/or collapsible to allow distal retention element 4320 to collapsedinto and delivered with a delivery needle.

FIG. 24J shows tissue anchor 4300 with another embodiment of a tissueingrowth element 4360. Tissue ingrowth element 4360 may include one ormore covers 4366. Each cover 4366 may at least partially cover proximalside 4341 and distal side 4342 of a petal 4340. Covers 4366 may bestitched or otherwise coupled to themselves or to petals 4340.Alternatively, covers 4366 may be configured to retain themselves overpetals 4340. For example, covers 4366 may be sufficiently elastic to fitover petals 4340 and retain themselves over petals 4340. Covers 4366 maybe coupled to proximal end 4331 and/or distal end 4332 of hub 4330, suchas to inner tube 4334 of hub 4330. Covers 4366 may be coupled to hub4330 by melt welding, or any other suitable method. Covers 4366 may besufficiently compressible and/or collapsible to allow distal retentionelement 4320 to collapsed into and delivered with a delivery needle.

FIG. 24K shows tissue anchor 4300 with another embodiment of a tissueingrowth element 4360. Tissue ingrowth element 4360 may include awebbing 4367. Webbing 4367 may be formed at least partially in open area4344 of one or more petals 4340. Alternatively, or in addition, webbing4367 may be formed at least partially in one or more areas betweenpetals 4340. Webbing 4367 may be coupled to petals 4340 by melt welding,or any other suitable method. Webbing 4367 may be sufficientlycompressible and/or collapsible to allow distal retention element 4320to collapsed into and delivered with a delivery needle.

Tissue ingrowth element 4360 may be used with any suitable tissueanchor, such as a T-tag. Tissue ingrowth element 4360 may be used withany suitable distal retention element, such as those described in U.S.Pat. Nos. 8,070,743 and 8,182,459, and U.S. Patent ApplicationPublication 2009/0012541. Tissue ingrowth element 4360 may be used withany suitable frame or structure that is collapsible, compressible,and/or may be delivered inside a delivery needle.

Tissue ingrowth element 4360 may include a mesh made of fabric, plastic,metal, or any other suitable material. For example, tissue ingrowthelement 4360 may include a knitted or woven material made of a polyesteror polypropylene. Tissue ingrowth element 4360 may have a mesh size thatallows or promotes tissue ingrowth, such as a mesh size ranging fromabout 6 μm to about 2.5 mm. Tissue ingrowth element 4360 may also have amesh size large enough to permit macrophages to pass through, such as amesh size greater than about 80-100 μm.

FIGS. 5A-5C show one embodiment of a tissue marking device 1400.

FIG. 5A shows a perspective view of tissue marking device 1400. FIG. 5Bshows an enlarged cross-sectional view of a distal portion of tissuemarking device 1400.

FIG. 5C shows an enlarged end view of a distal portion tissue markingdevice 1400.

Tissue marking device 1400 may be used for aiding the placement oftissue anchors, identifying cancerous tissue, marking tissue beforesurgery, and other purposes where a temporary or permanent marking ofthe anatomy is desired. In some embodiments, tissue marking device 1400may be used for purposes other than marking, such as for pinpointdelivery of a diagnostic or therapeutic agent into tissue, such as achemotherapeutic drug for example.

Tissue marking device 1400 may include a marking tube 1410, a markingtip 1420, a dye source 1444, and a vacuum source 1460.

Marking tube 1410 includes a proximal portion 1411 and a distal portion1412. Marking tube includes an inlet lumen 1413 and an outlet lumen1415. Marking tube 1410 is configured to access a part of the body wherethe tissue is located. Marking tube 1410 may be configured to be used ina working channel of an endoscope or other device.

Marking tip 1420 may be formed at distal portion 1412 of marking tube1410. Marking tip 1420 includes a passage 1421 formed in a wall 1414between inlet lumen 1413 and outlet lumen 1415. Marking tip 1420includes an opening 1426. Opening 1426 may be circular, cross-shaped,X-shaped, or any other suitable size and shape as desired for aparticular tissue identification, and in some embodiments could have afirst opening shape to mark a first tissue, and a second opening shapeto mark a second tissue. Opening 1426 may be chamfered on the insideand/or outside. Marking tip 1420 is configured to be placed against atissue to be marked. Marking tip 1420 may be any suitable size or shapedepending on the tissue to be marked. Opening 1426 could be on adistal-facing surface of marking tip 1420 as illustrated, or on asidewall of the marking tip 1420 in other embodiments, such as describedin connection with FIGS. 7A-7E below.

Dye source 1444 may be coupled to inlet lumen 1413. Dye source 1444 maybe a reservoir containing a dye for marking tissue. The dye may begentian violet or any other suitable ink or dye. Dye source 1444 may bea syringe or other device which allows the flow of the dye to becontrolled.

Optionally, a rinse source 1445 may be coupled to inlet lumen 1413.Rinse source 1445 may be a reservoir containing a rinse solution such assaline or water. Rinse source 1445 may be a syringe or other devicewhich allows the flow of the rinse solution to be controlled.

A single solution may be used which performs both functions of the dyeand the rinse solution.

A manifold 1450 may be used to couple dye source 1444 and rinse source1445 to inlet lumen 1413. Manifold 1450 may include one or more valves1451 which allow dye source 1444 and rinse source 1445 to be turned onand off independently.

Vacuum source 1460 may be coupled to outlet lumen 1415. Vacuum source1460 may be a pump or other suitable device. Vacuum source 1460 isconfigured to draw a tissue placed against marking tip 1420 and create aseal between opening 1426 and the tissue. Vacuum source 1460 is alsoconfigured to fill marking tip 1420 with a dye from dye source 1444 anda rinse solution from rinse source 1445. Vacuum source 1460 may includecontrols for adjusting or programming time and pressure of vacuumapplied.

Tissue marking device 1400 may be a sealed system, which allows for agiven fluid to be maintained in marking tip 1420 as long as a vacuum isapplied and a seal with the tissue is maintained.

Tissue marking device 1400 may be used by first applying a vacuum tomarking tip 1420 to draw a portion of the tissue against opening 1426,and then providing a dye to marking tip 1420 to at least partially fillmarking tip 1420 with the dye and allow the dye to contact the portionof the tissue and mark the tissue. Tissue marking device 1400 may alsobe used to provide a rinse solution to marking tip 1420 to at leastpartially fill marking tip 1420 with the rinse solution and rinse theportion of the tissue. Tissue marking device 1400 may also be used toprovide a prep solution to marking tip 1420 to at least partially fillmarking tip 1420 with the prep solution and prepare the portion of thetissue before providing the dye.

FIGS. 6A-6D show one embodiment of a method for using tissue markingdevice 1400.

FIG. 6A shows positioning marking tip 1420 against a tissue to bemarked. An endoscope S may be used to place marking tip 1420 against thetissue.

FIG. 6B shows drawing the tissue against marking tip 1420. Vacuum source1460 is turned on to create a vacuum in marking tip 1420. Vacuum source1460 draws the tissue against marking tip 1420, creating a seal betweenopening 1426 and the tissue.

FIG. 6C shows marking the tissue. Valve 1451 for dye source 1444 isopened and vacuum source 1460 fills marking tip 1420 with a dye from dyesource 1444 to mark the tissue exposed through opening 1426. Vacuumsource 1460 may be used to maintain the dye in marking tip 1420 for alength of time to allow the dye to penetrate into the tissue. The dyemay then be evacuated from marking tip 1420.

Optionally, rinsing marking tip 1420 and/or the tissue may be performed.Valve 1451 for rinse source 1445 is opened and vacuum source 1460 fillsmarking tip 1420 with a rinse solution from rinse source 1445.

FIG. 6D shows marking tip 1420 removed from the tissue, showing thetissue mark.

FIG. 7A shows one embodiment of a tissue marking device 2400. FIGS.7B-7D show various embodiments of marking surface 2420. FIG. 7E showsvarious embodiments of openings 2426.

Tissue marking device 2400 may be used for aiding the placement oftissue anchors, identifying cancerous tissue, marking tissue beforesurgery, and other purposes. In some embodiments, tissue marking device2400 may be used for purposes other than marking, such as for pinpointdelivery of a diagnostic or therapeutic agent into tissue, such as achemotherapeutic drug for example.

Tissue marking device 2400 may include an access element 2410, a markinginterface 2420, a positioning element 2430, a dye source 2444, and avacuum source 2460.

Access element 2410 includes a proximal portion 2411 and a distalportion 2412. Access element 2410 may include an inlet tube 2413 and anoutlet tube 2415. Access element 2410 is configured to access a part ofthe body where the tissue is located. In one embodiment, an accesselement 2410 used for esophageal access may be a catheter of suitablelength and diameter to access the gastroesophageal junction or otherpart of the esophagus. Access element 2410 may be configured to be usedwith a visualization device. In other embodiments, access element 2410may be an endoscope, a solid elongate member, or other suitable deviceused to access the esophagus or other bodily cavities.

Marking surface 2420 may be coupled to distal portion 2412 of accesselement 2410. Alternatively, marking surface 2420 may be coupled to anysuitable part of access element 2410. Marking surface 2420 includes alumen 2421 having an inlet 2423 and an outlet 2425. Inlet 2423 andoutlet 2425 may be coupled to inlet tube 2413 and outlet tube 2415.Lumen 2421 may be linear, meandering, or U-shaped, as shown in FIGS.7B-7D, or any other suitable configuration. Lumen 2421 may include oneor more gaps 2422 for visualization. Marking surface 2420 includes oneor more openings 2426. Openings 2426 may be arranged in one or more rowsthat can be regularly or irregularly spaced apart. Regularly spacedapart rows may be advantageous, for example, for calibration ormeasuring of distances. Openings 2426 may be circular, cross-shaped,X-shaped, or any other suitable size and shape as desired for aparticular tissue identification, and in some embodiments could have afirst opening shape to mark a first tissue, and a second opening shapeto mark a second tissue. Openings 2426 may be chamfered on the insideand/or outside. Marking surface 2420 is configured to be placed againsta tissue to be marked. Marking surface 2420 may be any suitable size orshape depending on the tissue to be marked. In one embodiment, markingsurface 2420 may simply be a tube with one or more openings 2426 formedin a side of the tube.

Positioning element 2430 may be coupled to distal portion 2412 of accesselement 2410. Positioning element 2430 may be an expandable element,such as balloon, expandable mesh, or other suitable device. Positioningelement 2430 may be coupled a known distance proximal or distal tomarking surface 2420. Positioning element 2430 may be used to positionmarking surface 2420 with respect to an anatomical feature. In oneembodiment, positioning element 2430 is a balloon configured to beexpanded in the stomach, and configured to position marking surface 2420in the esophagus a known distance from the opening of the stomach.

Optionally, a first rinse source 2441 may be coupled to inlet tube 2413.First rinse source 2441 may be a reservoir containing a first rinsesolution such as saline or water. First rinse source 2441 may be asyringe or other device which allows the flow of the first rinsesolution to be controlled.

Optionally, a second rinse source 2442 may be coupled to inlet tube2413. Second rinse source 2442 may be a reservoir containing a secondrinse solution such as acetic acid. Second rinse source 2442 may be asyringe or other device which allows the flow of the second rinsesolution to be controlled.

Optionally, a prep source 2443 may be coupled to inlet tube 2413. Prepsource 2443 may be a reservoir containing a prep solution such asisopropyl alcohol. Prep source 2443 may be a syringe or other devicewhich allows the flow of the prep solution to be controlled.

Dye source 2444 may be coupled to inlet tube 2413. Dye source 2444 maybe a reservoir containing a dye for marking tissue. The dye may begentian violet or any other suitable ink or dye. Dye source 2444 may bea syringe or other device which allows the flow of the dye to becontrolled.

Optionally, a third rinse source 2445 may be coupled to inlet tube 2413.Third rinse source 2445 may be a reservoir containing a third rinsesolution such as saline or water. Third rinse source 2445 may be asyringe or other device which allows the flow of the third rinsesolution to be controlled.

A single solution may be used which performs two or more functions ofthe first rinse solution, second rinse solution, prep solution, dye, andthird rinse solution.

A manifold 2450 may be used to couple first rinse source 2441, secondrinse source 2442, prep source 2443, dye source 2444, and third rinsesource 2445 to inlet tube 2413. Manifold 2450 may include one or morevalves 2451 which allow first rinse source 2441, second rinse source2442, prep source 2443, dye source 2444, and third rinse source 2445 tobe turned on and off independently.

Vacuum source 2460 is coupled to outlet tube 2415. Vacuum source 2460may be a pump or other suitable device. Vacuum source 2460 is configuredto create a vacuum within lumen 2421 of marking surface 2420. Vacuumsource 2460 is configured to draw a tissue placed against markingsurface 2420 and create a seal between openings 2426 and the tissue.Vacuum source 2460 is configured to fill lumen 2421 with a first rinsesolution from first rinse source 2441, a second rinse solution fromsecond rinse source 2442, a prep solution from prep source 2443, a dyefrom dye source 2444, and/or a third rinse solution from third rinsesource 2445. Vacuum source 2460 may include controls for adjusting orprogramming time and pressure of vacuum applied.

Tissue marking device 2400 may be a sealed system, which allows for agiven fluid to be maintained in lumen 2421 as long as a vacuum isapplied and a seal with the tissue is maintained.

Tissue marking device 2400 may be used to first apply a vacuum to outlet2425 of lumen 2421 to draw a portion of the tissue against opening 2426,and then to provide a dye to inlet 2423 of lumen 2421 to at leastpartially fill lumen 2421 with the dye and allow the dye to contact theportion of the tissue and mark the tissue. Tissue marking device 2400may also be used to provide a rinse solution to inlet 2423 of lumen 2421to at least partially fill lumen 2421 with the rinse solution and rinsethe portion of the tissue. Tissue marking device 2400 may also be usedto provide a prep solution to inlet 2423 of lumen 2421 to at leastpartially fill lumen 2421 with the prep solution and prepare the portionof the tissue before providing the dye.

FIGS. 8A-8F show one embodiment of a method for using tissue markingdevice 2400.

FIG. 8A shows introducing access element 2410 into a first location,e.g., the esophagus and introducing positioning element 2430 into asecond location, e.g., the stomach which in some embodiments may bedistal to the first location.

FIG. 8B shows expanding positioning element 2430 in the stomach.

FIG. 8C shows seating positioning element 2430 against the opening ofthe stomach to position marking surface 2420 a known distance from theopening of the stomach in the esophagus. Alternatively, marking surface2420 may be positioned using an initial mark made previously by tissuemarking device 1400.

FIG. 8D shows drawing the tissue against marking surface 2420. Vacuumsource 2460 is turned on to create a vacuum in lumen 2421. Vacuum source2460 draws the tissue against marking surface 2420, creating a sealbetween openings 2426 and the tissue.

Optionally, rinsing the tissue may be performed one or more times. Valve2451 for first rinse source 2441 is opened and vacuum source 2460 fillslumen 2421 with a first rinse solution from first rinse source 2441 torinse the tissue exposed through openings 2426. Valve 2451 for secondrinse source 2442 is opened and vacuum source 2460 fills lumen 2421 witha second rinse solution from second rinse source 2442 to rinse thetissue exposed through openings 2426.

Optionally, preparing the tissue may be performed. Valve 2451 for prepsource 2443 is opened and vacuum source 2460 fills lumen 2421 with aprep solution from prep source 2443 to prepare the tissue exposedthrough openings 2426.

FIG. 8E shows marking the tissue. Valve 2451 for dye source 2444 isopened and vacuum source 2460 fills lumen 2421 with a dye from dyesource 2444 to mark the tissue exposed through openings 2426. Vacuumsource 2460 may be used to maintain the dye in lumen 2421 for a lengthof time to allow the dye to penetrate into the tissue. The dye is thenevacuated from lumen 2421.

Optionally, rinsing lumen 2421 and/or the tissue may be performed. Valve2451 for third rinse source 2445 is opened and vacuum source 2460 fillslumen 2421 with a third rinse solution from third rinse source 2445 torinse lumen 2421 and/or the tissue exposed through openings 2426.

FIG. 8F shows marking surface 2420 removed from the tissue, showing thetissue marks.

FIGS. 9A-9C show one embodiment of a sleeve delivery device 1500. FIG.9A shows a perspective view of sleeve delivery device 1500. FIG. 9Bshows an enlarged view of a distal portion of sleeve delivery device1500. FIG. 9C shows a cross-sectional view of sleeve delivery device1500.

Sleeve delivery device 1500 may be used to deliver a gastrointestinalsleeve. Sleeve delivery device 1500 may also be used to deliver agastrointestinal cuff together with or apart from a gastrointestinalsleeve.

Sleeve delivery device 1500 may include a handle 1510, a deliverycatheter 1520, a sealing element 1540, a release element 1550, and apump 1570.

Handle 1510 may include a sealing port 1514, a release port 1515, a pumpport 1517, and a snare port 1518. Snare port 1518 is configured toreceive a loop snare or other grasping device.

Delivery catheter 1520 includes a proximal portion 1521 and a distalportion 1522. Proximal portion 1521 is coupled to handle 1510. Distalportion 1522 is configured to receive a proximal portion of agastrointestinal sleeve. Distal portion 1522 may be curved to facilitateplacement into the pylorus and/or intestine. Delivery catheter 1520includes a delivery lumen 1523, a sealing lumen 1524, and a releaselumen 1525. Delivery lumen 1523 is configured to receive at least adistal portion of a gastrointestinal sleeve which may be inverted insidedelivery lumen 1523. Sealing lumen 1524 is in communication with asealing opening 1534 formed in a side of distal portion 1522. Releaselumen 1525 is in communication with a release opening 1535 formed in aside of distal portion 1522.

Sealing element 1540 is configured to form a substantially fluid-tightseal between a proximal portion of a sleeve, such as a gastrointestinalsleeve, and distal portion 1522 of delivery catheter 1520, when aproximal portion of a gastrointestinal sleeve is placed over distalportion 1522 of delivery catheter 1520. Sealing element 1540 is alsoconfigured to retain a gastrointestinal sleeve to delivery catheter 1520during delivery. Sealing element 1540 may be, for example, a suture,wire, or other means that runs through sealing lumen 1524, exits out ofsealing opening 1534, and wraps one or more times around a proximalportion of a gastrointestinal sleeve placed over distal portion 1522 ofdelivery catheter 1520. Sealing element 1540 may include a distalportion 1542 having a loop or a ring.

Release element 1550 is slidably disposed in release lumen 1525. Releaseelement 1550 is configured to retain a distal portion 1542 of sealingelement 1540. Release element 1550 is exposed at release opening 1535.Release element 1550 may be a wire. Alternatively, release element 1550may be a suture or other suitable device.

Pump 1570 is configured to be coupled to pump port 1517. Pump 1570 isconfigured to pump a fluid such as water into delivery lumen 1523 toevert a gastrointestinal sleeve loaded onto delivery catheter 1520. Pump1570 may include controls for pressure, volume, flow rate, time, orother parameters.

FIGS. 9D-9G show one embodiment of a method for loading sleeve deliverydevice 1500. FIG. 9D shows placing a proximal portion of agastrointestinal sleeve over distal portion 1522 of delivery catheter1520. FIG. 9E shows wrapping sealing element 1540 around the proximalportion of the gastrointestinal sleeve. FIG. 9F shows securing distalportion 1542 of sealing element 1540 in release opening 1535 usingrelease element 1550. FIG. 9G shows tightening of sealing element 1540around the proximal portion of the gastrointestinal sleeve. The loadingmay be completed by inserting a grasper, such as a loop snare throughdelivery lumen 1523 and the gastrointestinal sleeve, sealing a distalportion of the gastrointestinal sleeve, and using the loop snare to pullthe distal portion of the gastrointestinal sleeve into delivery lumen1523 to invert the gastrointestinal sleeve into delivery lumen 1523.Further examples of everting systems and methods that can be used withthe systems and methods disclosed herein can be found, for example, inU.S. Pat. No. 8,118,774 and U.S. Pat. Pub. No. 2007/0198074, both ofwhich are incorporated by reference in their entireties.

FIGS. 10A-10C show another embodiment of a sleeve delivery device 2500.FIG. 10A shows a perspective view of sleeve delivery device 2500. FIG.10B shows an enlarged view of a distal portion of sleeve delivery device2500. FIG. 10C shows a cross-sectional view of sleeve delivery device2500.

Sleeve delivery device 2500 may be used to deliver a gastrointestinalsleeve. Sleeve delivery device 2500 may also be used to deliver agastrointestinal cuff together with or apart from a gastrointestinalsleeve.

Sleeve delivery device 2500 may include a handle 2510, a deliverycatheter 2520, a sealing element 2540, one or more rings 2550, and apump 2570.

Handle 2510 may include a sealing port 2514, a pump port 2517, and asnare port 2518. Snare port 2518 is configured to receive a loop snareor other grasping device.

Delivery catheter 2520 includes a proximal portion 2521 and a distalportion 2522. Proximal portion 2521 is coupled to handle 2510. Distalportion 2522 is configured to receive a proximal portion of agastrointestinal sleeve. Distal portion 2522 may be curved to facilitateplacement into the pylorus and/or intestine. Delivery catheter 2520includes a delivery lumen 2523 and a sealing lumen 2524. Delivery lumen2523 is configured to receive at least a distal portion of agastrointestinal sleeve which may be inverted inside delivery lumen2523. Sealing lumen 2524 is in communication with a sealing opening 2534formed in a side of distal portion 2522.

Sealing element 2540 is configured to form a substantially fluid-tightseal between a proximal portion of a sleeve, such as a gastrointestinalsleeve, and distal portion 2522 of delivery catheter 2520, when aproximal portion of a gastrointestinal sleeve is placed over distalportion 2522 of delivery catheter 2520. Sealing element 2540 is alsoconfigured to retain a gastrointestinal sleeve to delivery catheter 2520during delivery. Sealing element 2540 may be, for example, a suture,wire, or other means that runs through sealing lumen 2524, exits out ofsealing opening 2534, and wraps one or more times around a proximalportion of a gastrointestinal sleeve placed over distal portion 2522 ofdelivery catheter 2520. Sealing element 2540 may include a distalportion 2542 that may be tied to sealing element 2540 with a releasableknot.

Rings 2550, which may include any radially outwardly protrudingstructure, may be formed or coupled around distal portion 2522 ofdelivery catheter 2520. Rings 2550 may be coupled with heat shrinktubing, an adhesive, or other suitable methods. Rings 2550 areconfigured to fit inside a proximal portion of a gastrointestinalsleeve. Rings 2550 may cooperate with sealing element 2540 to help sealand retain a proximal portion of a gastrointestinal sleeve around distalportion 2522 of delivery catheter 2520.

Pump 2570 is configured to be coupled to pump port 2517. Pump 2570 isconfigured to pump a fluid such as water into delivery lumen 2523 toevert a gastrointestinal sleeve loaded onto delivery catheter 2520. Pump2570 may include controls for pressure, volume, flow rate, time, orother parameters.

FIGS. 10D-10G show one embodiment of a method for loading sleevedelivery device 2500. FIG. 10D shows placing a proximal portion of agastrointestinal sleeve over distal portion 2522 of delivery catheter2520 and over rings 2550. FIG. 10E shows wrapping sealing element 2540around the proximal portion of the gastrointestinal sleeve between tworings 2550. FIG. 10F shows securing sealing element 2540 to itself bytying a knot that will release when pulled, such as a slip knot. FIG.10G shows tightening of sealing element 2540 around the proximal portionof the gastrointestinal sleeve. The loading may be completed byinserting a grasper, such as a loop snare, through delivery lumen 2523and the gastrointestinal sleeve, sealing a distal portion of thegastrointestinal sleeve, and using the loop snare to pull the distalportion of the gastrointestinal sleeve into delivery lumen 2523 toinvert the gastrointestinal sleeve into delivery lumen 2523. Furtherexamples of everting systems and methods that can be used with thesystems and methods disclosed herein can be found, for example, in U.S.Pat. No. 8,118,774 and U.S. Pat. Pub. No. 2007/0198074, both of whichare incorporated by reference in their entireties.

FIGS. 11A-11C show yet another embodiment of a sleeve delivery device3500. FIG. 11A shows a perspective view of sleeve delivery device 3500.FIG. 11B shows an enlarged view of a distal portion of sleeve deliverydevice 3500. FIG. 11C shows a cross-sectional view of sleeve deliverydevice 3500.

Sleeve delivery device 3500 may be used to deliver a gastrointestinalsleeve. Sleeve delivery device 3500 may also be used to deliver agastrointestinal cuff together with or apart from a gastrointestinalsleeve.

Sleeve delivery device 3500 may include a handle 3510, a deliverycatheter 3520, a balloon 3540, a boot 3560, and a pump 3570.

Handle 3510 may include an inflation port 3514, a boot release port3516, a pump port 3517, and a snare port 3518. Inflation port 3514 isconfigured to be coupled to an inflation source. Snare port 3518 isconfigured to receive a loop snare or other grasping device.

Delivery catheter 3520 includes a proximal portion 3521 and a distalportion 3522. Proximal portion 3521 is coupled to handle 3510. Distalportion 3522 is configured to receive a proximal portion of agastrointestinal sleeve. Distal portion 3522 may be curved to facilitateplacement into the pylorus and/or intestine. Delivery catheter 3520includes a delivery lumen 3523, an inflation lumen 3524, and a bootrelease lumen 3526. Delivery lumen 3523 is configured to receive atleast a distal portion of a gastrointestinal sleeve which may beinverted inside delivery lumen 3523. Inflation lumen 3524 is incommunication with balloon 3540. Boot release lumen 3526 is incommunication with a boot release opening 3536 formed in a side ofdistal portion 3522.

Balloon 3540 is coupled to distal portion 3522 of delivery catheter3520. Balloon 3540 is configured to form a substantially fluid-tightseal between a proximal portion of a sleeve, such as a gastrointestinalsleeve, and distal portion 3522 of delivery catheter 3520, when aproximal portion of a gastrointestinal sleeve is placed over distalportion 3522 of delivery catheter 3520. Balloon 3540 is also configuredto retain a gastrointestinal sleeve to delivery catheter 3520 duringdelivery. Balloon 3540 may be a circumferential balloon coupled arounddistal portion 3522 of delivery catheter 3520.

Boot 3560 is configured to wrap around a proximal portion of agastrointestinal sleeve placed over distal portion 3522 of deliverycatheter 3520. Boot 3560 is configured to prevent damage to or snaggingof a proximal portion of a gastrointestinal sleeve during delivery. Boot3560 has an outside profile configured to minimize trauma and damage toesophagus and other tissue during delivery. Boot 3560 may also help toretain a gastrointestinal sleeve to delivery catheter 3520. Boot 3560includes a boot release 3561. Boot release 3561 may be, for example, asuture, wire, or other means that runs through boot release lumen 3526,exits out of boot release opening 3536, and attaches to boot 3560. Bootrelease 3561 is configured to unzip, tear open, cut, degrade, orotherwise disassociate boot 3560 to release it from delivery catheter3520. Boot 3560 may include perforations 3562 and a tongue 3563 tofacilitate release. Boot 3560 may be made of plastic, fabric, or othersuitable material. When sleeve delivery device 3500 is used to deliver agastrointestinal cuff together with a gastrointestinal sleeve, boot 3560may be long enough to wrap around both the gastrointestinal cuff and theproximal portion of the gastrointestinal sleeve. A boot 3560 may also beused with sleeve delivery devices 1500 and 2500.

Pump 3570 is configured to be coupled to pump port 3517. Pump 3570 isconfigured to pump a fluid such as water into delivery lumen 3523 toevert a gastrointestinal sleeve loaded onto delivery catheter 3520. Pump3570 may include controls for pressure, volume, flow rate, time, orother parameters.

FIGS. 11D-11G show one embodiment of a method for loading sleevedelivery device 3500. FIG. 11D shows placing a proximal portion of agastrointestinal sleeve over distal portion 3522 of delivery catheter3520 and over balloon 3540. FIG. 11E shows folding the proximal portionof the gastrointestinal sleeve around distal portion 3522 of deliverycatheter 3520. The loading may be continued by inserting a grasper, suchas a loop snare, through delivery lumen 3523 and the gastrointestinalsleeve, sealing a distal portion of the gastrointestinal sleeve, andusing the loop snare to pull the distal portion of the gastrointestinalsleeve into delivery lumen 3523 to invert the gastrointestinal sleeveinto delivery lumen 3523. FIG. 11F shows wrapping boot 3560 around thenow folded proximal portion of the gastrointestinal sleeve and attachingboot 3560 to boot release 3561. FIG. 11G shows inflating balloon 3540.Further examples of everting systems and methods that can be used withthe systems and methods disclosed herein can be found, for example, inU.S. Pat. No. 8,118,774 and U.S. Pat. Pub. No. 2007/0198074, both ofwhich are incorporated by reference in their entireties.

FIGS. 12A-12C show one embodiment of an anchor delivery device 1600.FIG. 12A shows a perspective view of anchor delivery device 1600. FIG.12B shows an exploded view of anchor delivery device 1600. FIG. 12Cshows an enlarged cross-sectional view of a distal portion of anchordelivery device 1600 with a tissue anchor loaded.

Anchor delivery device 1600 includes a handle 1610, a sheath 1650, adelivery needle 1660, and a stylet 1670.

Handle 1610 includes a needle control 1616 and a stylet control 1617.

Sheath 1650 includes a proximal portion 1651, a distal portion 1652, anda sheath lumen 1655. Proximal portion 1651 of sheath 1650 may be coupledto handle 1610. Sheath 1650 is configured to be slidably disposed in aworking lumen of an endoscope.

Delivery needle 1660 is slidably disposed in sheath lumen 1655. Deliveryneedle 1660 includes a proximal portion 1661, a distal portion 1662, anda needle lumen 1665. Proximal portion 1661 may be coupled to needlecontrol 1616. Distal portion 1662 may include a tip 1668 that is sharp.Alternatively, tip 1668 may be atraumatic and coupled to an RF or otherenergy source. Distal portion 1662 may be advanced out of and refractedinto sheath 1620. Distal portion 1662 may be preformed with a curve, ormade of a shape memory material. This curve may be straightened out whendistal portion 1662 is retracted into sheath 1620. Distal portion 1662may be made of the same material as the rest of delivery needle 1660.Alternatively, distal portion 1662 may be made of a different materialfor greater curve and/or flexibility. For example, distal portion 1662may be made of a polyamide and the rest of delivery needle 1660 may bemade of nitinol. Delivery needle 1660 is configured to receive a tissueanchor collapsed into a delivery configuration.

Stylet 1670 is slidably disposed in needle lumen 1665. Stylet 1670includes a proximal portion 1671 and a distal portion 1672. Proximalportion 1671 may be coupled to stylet control 1617. Distal portion 1672may be advanced out of and retracted into delivery needle 1660. Stylet1670 is configured to push out a tissue anchor loaded in delivery needle1660.

FIGS. 13A-13E show one embodiment of a method for using anchor deliverydevice 1600. Other systems and methods that can be used or modified foruse with anchor delivery devices as described herein can be found, forexample, in U.S. Pat. Pub. No. 2009/0012541 to Dahl et al., which ishereby incorporated by reference in its entirety.

FIG. 13A shows loading anchor delivery device 1600 with a tissue anchor,e.g., tissue anchor 1300. Tissue anchor 1300A, tissue anchor 2300,tissue anchor 3300, tissue anchor 4300, and/or any other suitable tissueanchor may also be used. Delivery needle 1660 is refracted inside sheath1650. A distal retention element of a tissue anchor is loaded intodelivery needle 1660. A proximal retention element of tissue anchor 1300hangs outside of delivery needle 1660. A therapeutic agent, e.g., anantibiotic gel, may also be loaded into delivery needle 1660.

FIG. 13B shows advancing delivery needle 1660 through sheath 1650 andtransmurally through a tissue wall W. The proximal retention element ismaintained on a proximal side of the tissue wall W, e.g., on a mucosalsurface. In other embodiments tissue anchor 1300 may be placed through aplication.

FIG. 13C shows advancing stylet 1640 through delivery needle 1630 todeploy the distal retention element on a distal side of the tissue wallW, e.g., on a serosal surface. The antibiotic gel may also be pushedout.

FIG. 13D shows positioning and/or turning over tissue anchor 1300 asnecessary using laparoscopic instruments positioned on the distal sideof the tissue wall W.

FIG. 13E shows retracting delivery needle 1660 back through the tissuewall and back into sheath 1650, leaving a tension element of tissueanchor 1300 in place through the tissue wall W.

FIGS. 14A-14C show one embodiment of a stent 1690. FIG. 14A shows a topview of stent 1690. FIG. 14B shows stent 1690 in an collapsedconfiguration coupled to a gastrointestinal cuff. FIG. 14C shows stent1690 in an expanded configuration coupled to a gastrointestinal cuff.

Stent 1690 may be removably coupled to a gastrointestinal cuff to createa working space inside the esophagus. Stent 1690 may also be usedwithout being coupled to the gastrointestinal cuff. Stent 1690 may beused in conjunction with anchor delivery device 1600.

Stent 1690 includes a plurality of proximal segments 1691 and aplurality of distal segments 1692 connected by connecting segments 1693.Proximal segments 1691 may include proximal drawstring holes 1694. Aproximal drawstring 1695 may be threaded through proximal drawstringholes 1692. A proximal drawstring control 1696 may be coupled toproximal drawstring 1695. Proximal drawstring control 1696 is configuredto loosen and tighten proximal drawstring 1695 to expand and collapse aproximal portion of stent 1690. Distal segments 1692 may include distaldrawstring holes 1697. A distal drawstring 1698 may be threaded throughdistal drawstring holes 1697. A distal drawstring control 1699 may becoupled to distal drawstring 1698. Distal drawstring control 1699 isconfigured to loosen and tighten distal drawstring to expand andcollapse a distal portion of stent 1690.

Stent 1690 may be removably coupled to an inner surface of a proximalportion of a gastrointestinal cuff. Stent 1690 may be sutured to thegastrointestinal cuff. Stent 1690 may be delivered in a collapsedconfiguration together with the gastrointestinal cuff, and expanded at acuff position to create a working space. When the working space is nolonger needed, the sutures may be cut and removed, and stent 1690collapsed and removed.

Stent 1690 may also be used without being coupled to a gastrointestinalcuff. Stent 1690 may be delivered in a collapsed configuration into apreviously placed gastrointestinal cuff, and expanded to create aworking space. When the working space is no longer needed, the stent1690 may be collapsed and removed.

FIGS. 15A-15G show another embodiment of an anchor delivery device 2600.FIG. 15A shows a perspective view of anchor delivery device 2600. FIG.15B shows an exploded view of anchor delivery device 2600. FIG. 15Cshows a side cross-sectional view of a distal portion of anchor deliverydevice 2600. FIG. 15D shows a side cross-sectional view of a distalportion of sled 2650. FIG. 15E shows a side view of a delivery needle2660, a pushrod 2670, and a holder 2680. FIG. 15F shows an enlarged viewof a delivery needle 2660 and a pushrod 2670. FIG. 15G shows an endcross-sectional view of a distal portion of anchor delivery device 2600.

Anchor delivery device 2600 includes a handle 2610, a catheter 2620, aside port 2630, a sled 2650, a delivery needle 2660, pushrod 2670, and aholder 2680.

Handle 2610 includes a needle control 2616, a pushrod control 2617, anda holder control 2618.

Catheter 2620 includes a proximal portion 2621, a distal portion 2622,and a longitudinal axis 2623. Catheter 2620 also includes a centrallumen 2625. Distal portion 2622 may include a nose 2626 having anopening 2627. Nose 2626 may be soft and flexible. Nose 2626 may beelongate. Nose 2626 may be curved. Opening 2627 may be configured toallow an endoscope or other tool to pass through. Distal portion 2622may also include an alignment slot 2628 and a stop 2629.

Side port 2630 is formed in a side of distal portion 2622 of catheter2620. Side port 2630 includes a proximal side 2631 and a distal side2632. Side port 2630 may optionally include a tissue brace 2634 slidablydisposed within a brace lumen of catheter 2620. Tissue brace 2634 may beconfigured to removably cover side port 2630 to prevent tissue fromprematurely entering side port 2630. Side port 2630 may be coupled to avacuum source. Side port 2630 may be configured to be placed against anddraw in a tissue wall. Side port 2630 may be sized larger to allowenough of a tissue wall to be drawn in for single-wall (transmural)anchor delivery, or sized smaller for double-wall (plication) anchordelivery. For single-wall anchor delivery, side port 2630 may have alength of 10 mm to 50 mm or greater, such as a length of 20 mm to 30 mm.

Sled 2650 is slidably disposed in central lumen 2625. Sled 2650 includesa sheathing channel 2655 having a proximal opening 2656. Sled 2650 maybe coupled to a sled control rod 2657 configured to move sled 2650. Sledcontrol rod 2657 may be coupled to handle 2610. Sled 2650 may include analignment tab 2658 which cooperates with alignment slot 2628 to alignproximal opening 2656 with side port 2630. Sled 2650 may be configuredto slide in central lumen 2625 distally until it reaches stop 2629. Whensled 2650 has reached stop 2629, proximal opening 2656 of sheathingchannel 2655 may be positioned at distal side 2632 of side port 2630.Sled 2650 may be removed from catheter 2620 for reloading.

Delivery needle 2660 is slidably disposed in sheathing channel 2655.Delivery needle 2660 includes a distal control portion 2661, a proximaldelivery portion 2662, and a needle lumen 2665. Distal control portion2661 may be coupled to a needle control rod 2667. Needle control rod2667 may be coupled to needle control 2616. Proximal delivery portion2662 includes a tip 2668 that is sharp. Alternatively, tip 2668 may beatraumatic and coupled to an RF or other energy source. Delivery needle2660 has a reverse orientation, with tip 2668 pointed proximally (e.g.,toward the oropharynx, when the device 2600 is deployedtransesophageally via an endoscopic technique) and movable from a first,e.g., distal retracted position to a second, e.g., proximal position fordelivering a tissue anchor across a body luminal wall. Proximal deliveryportion 2662 may be advanced out of and retracted into sheathing channel2655. When advanced out of sheathing channel 2655, proximal deliveryportion 2662 may enter distal side 2632 of side port 2630. Deliveryneedle 2660 is configured to receive a tissue anchor collapsed into adelivery configuration. Delivery needle 2660 may include a slot 2669configured to allow a tension element of a tissue anchor to passthrough.

Pushrod 2670 is slidably disposed in needle lumen 2664. Pushrod 2670includes a distal control portion 2671 and a proximal delivery portion2672. Distal control portion 2671 may be coupled to a pushrod controlrod 2677. Pushrod control rod 2677 may be coupled to pushrod control2617. Pushrod 2670 has a reverse orientation, with proximal deliveryportion 2672 pointed proximally. Proximal delivery portion 2672 may beadvanced out of and retracted into delivery needle 2660. Pushrod 2670 isconfigured to push out a tissue anchor loaded in delivery needle 2660.Pushrod 2670 may include at least a portion, e.g., proximal deliveryportion 2672, sized small enough to push against a hub of a tissueanchor without damaging the tissue anchor or a portion thereof, e.g.,the petals. Pushrod 2670 may include a channel 2679 configured to allowa tension element of a tissue anchor to pass through. Channel 2679 ofpushrod 2670 may be aligned with slot 2669 of delivery needle 2660.

Holder 2680 may be coupled to a holder control rod 2687. Holder controlrod 2687 may be coupled to holder control 2618. Holder 2680 may beconfigured to hold an anchor hole of a gastrointestinal cuff overproximal opening 2656 of sheathing channel 2655. Holder 2680 may beconfigured to hold an anchor hole of a gastrointestinal cuff over tip2668 of delivery needle 2660. Holder 2680 may be slidably and/orrotatably manipulated. Holder 2680 may be stowed when not in use.

The control rods may be arranged coaxially. For example, sled controlrod 2657 may be slidably disposed in a hollow pushrod control rod 2677,which is slidably disposed in a hollow needle control rod 2667, which isslidably disposed in a hollow holder control rod 2687, as shown in FIG.15G. As another example, pushrod control rod 2677 may be slidablydisposed in a hollow needle control rod 2667, which is slidably disposedin a hollow sled control rod 2657, which is slidably disposed in ahollow holder control rod 2687. Alternatively, the control rods may bearranged non-coaxially, such as in a multi-lumen carrier tube. In someembodiments, anchor delivery device 2600 may also include an integratedvacuum port operably connected to a source of vacuum. In someembodiments, the vacuum may be delivered via a port on a separateendoscope or other device.

FIGS. 16A-16F show one embodiment of a method for using anchor deliverydevice 2600. Sheathing lumen 2655 is represented by the cross-hatchedarea. For clarity, only delivery needle 2660 and pushrod 2670 are shown.

FIG. 16A shows loading delivery needle 2660. Sled 2650 is removed fromcatheter 2620. Pushrod 2670 is taken out of delivery needle 2660. Anantibiotic gel may be loaded into delivery needle 2660, which may reducethe likelihood of infection when delivery needle 2660 bridgesnon-sterile and sterile fields. A distal retention element of a tissueanchor, e.g., tissue anchor 1300, is loaded through distal controlportion 2661. Tissue anchor 1300A, tissue anchor 2300, tissue anchor3300, tissue anchor 4300, and/or any other suitable tissue anchor mayalso be used. A tension element of tissue anchor 1300 is passed throughslot 2669 and channel 2679. A proximal retention element is positionedoutside of delivery needle 2660.

FIG. 16B shows loading catheter 2620. Pushrod 2670 is inserted intodelivery needle 2660. The distal retention element is positioned insidetip 2668. Sled 2650 is inserted into catheter 2620 and seated in distalportion 2622. Proximal opening 2656 of sheathing channel 2655 ispositioned at distal side 2632 of side port 2630.

FIG. 16C shows capturing the gastrointestinal cuff. Holder 2680 may beused to hold an anchor hole of the gastrointestinal cuff over proximalopening 2656 of sheathing channel 2655. Delivery needle 2660 may beadvanced a small amount so that tip 2668 threads through the anchorhole. A tissue wall W is drawn in through side port 2630 using a vacuumsource. The tissue wall W at proximal side 2631 of side port 2630 may beat least partially drawn up into central lumen 2625 of catheter 2620.Tissue marks made previously, such as those made by tissue markingdevice 1400 and/or tissue marking device 2400, may be used to positiondelivery needle 2660.

FIG. 16D shows advancing delivery needle 2660. Delivery needle 2660 isadvanced through the tissue wall W at distal side 2632 of side port2630. Pushrod 2670 is also advanced, but is not moved relative todelivery needle 2660. Handle 2610 and needle control 2616 may beconfigured to preset the distance delivery needle 2660 is advanced toreduce the risk of penetrating the tissue wall W through proximal side2631 of side port 2630.

FIG. 16E shows retracting the delivery needle 2660. Delivery needle 2660is retracted while keeping pushrod 2670 in place to deploy the distalretention element. The antibiotic gel may also be released.

FIG. 16F shows stowing delivery needle 2660 and pushrod 2670. Deliveryneedle 2660 and pushrod 2670 are retracted into sheathing channel 2655.Anchor delivery device 2600 includes a delivery needle 2660 with areverse throw, which makes it convenient for use with anchor holes on aproximal portion of a gastrointestinal cuff. The reverse throw avoidsthe need to draw more of the gastrointestinal cuff into side port 2630.This and other anchor delivery systems and methods used herein can beused to accurately deliver one or a plurality of tissue anchors througha single transmural wall or to create or reinforce one or a plurality oftissue plications. Furthermore, anchor delivery system 2600 mayadvantageously reduce the risk of puncturing other body structures inclose proximity, e.g., the aorta. In some embodiments, anchor deliverysystems as described herein can be used via a pure endoscopic approach,e.g., as illustrated in connection with FIGS. 18A-18J below, withoutnecessarily requiring laparoscopic assistance.

FIGS. 17A-17H show one embodiment of a method for implanting agastrointestinal bypass device 1000. The method may also be used withother gastrointestinal bypass devices such as gastrointestinal bypassdevice 2000 and gastrointestinal bypass device 3000.

Sleeve delivery device 1500 is mounted with cuff 1100 and sleeve 1200.Sleeve delivery device 2500 or sleeve delivery device 3500 may also beused. Stent 1690 is coupled to cuff 1100. Stent 1690 is cinched aroundsleeve delivery device 1500.

FIG. 17A shows introducing sleeve delivery device 1500. Sleeve deliverydevice 1500 may position sleeve 1200 at or near the pylorus. Sleevedelivery device 1500 may be introduced with or without an overtube. Anendoscope may be used for guidance and visualization.

FIG. 17B shows deploying sleeve 1200. A fluid is pumped into deliverydevice 1500 to evert sleeve 1200 past the pylorus and into theintestine.

FIG. 17C shows positioning cuff 1100 and sleeve 1200 at the cuffposition. Sleeve delivery device 1500 pulls cuff 1100 and sleeve 1200proximally up to the gastroesophageal junction or other cuff positions,some of which are described elsewhere in the application.

FIG. 17D shows releasing cuff 1100 and sleeve 1200 from sleeve deliverydevice 1500. Sleeve delivery device 1500 is then withdrawn.

FIG. 17E shows introducing a laparoscopic tool L. Laparoscopic tool L ispositioned on a distal side of the cuff position. Laparoscopic tool Lmay be used to clear tissue around the esophagus to create a workingspace.

FIG. 17F shows introducing anchor delivery device 1600. Anchor deliverydevice 1600 may be used in the working lumen of an endoscope. Anchordelivery device 1600 may be introduced with or without an overtube.Anchor delivery device 1600 is positioned on a proximal side of the cuffposition. Stent 1690 is opened to create a working space.

FIG. 17G shows delivering tissue anchors 1300. Anchor delivery device1600 is delivers tissue anchors 1300 through cuff 1100 and the wall ofthe esophagus. Tissue anchor 1300A, tissue anchor 2300, tissue anchor3300, tissue anchor 4300, and/or any other suitable tissue anchor mayalso be used. Tissue marks made earlier by tissue marking device 1400may be used as a guide. Laparoscopic tool L may be held against thedistal side of the cuff position to reduce tenting. Laparoscopic tool Lmay be used to flip over distal retention element 1320 of tissue anchor1300.

FIG. 17H shows removing stent 1690 from cuff 1100. The sutures used tocouple stent 1690 to cuff 1100 may be cut and removed. Stent 1690 may becinched using proximal drawstring 1695 and/or distal drawstring 1698 andremoved. Stent 1690 may be removed with or without an overtube.

FIGS. 18A-18J show yet another embodiment of a method for implanting agastrointestinal bypass device 3000. The method may also be used withgastrointestinal bypass device 1000 and gastrointestinal bypass device2000.

Sleeve delivery device 1500 is mounted with cuff 3100 and sleeve 3200.Sleeve delivery device 2500 or sleeve delivery device 3500 may also beused.

FIG. 18A shows introducing sleeve delivery device 1500. Sleeve deliverydevice 1500 may position sleeve 3200 at or near the pylorus. Sleevedelivery device 1500 may be introduced with or without an overtube. Anendoscope may be used for guidance and visualization.

FIG. 18B shows deploying sleeve 3200. A fluid is pumped into deliverydevice 1500 to evert sleeve 3200 past the pylorus and into theintestine.

FIG. 18C shows positioning cuff 3100 and sleeve 3200 in the stomach.Sleeve delivery device 1500 pulls cuff 3100 and sleeve 3200 into thestomach.

FIG. 18D shows releasing cuff 3100 and sleeve 3200 from sleeve deliverydevice 1500. Sleeve delivery device 1500 is then withdrawn.

FIG. 18E shows introducing catheter 2620 of anchor delivery device 2600.Catheter 2260 of anchor delivery device 2600 is introduced through theesophagus. An endoscope may be used for guidance and visualization.

FIG. 18F shows grasping cuff 3100. A grasping tool is introduced throughcatheter 2260 to grasp cuff 3100 and pull cuff 3100 over catheter 2260.Sled 2650 is introduced into catheter 2260 and used to hold cuff 3100.

FIG. 18G shows positioning cuff 3100 and sleeve 3200 at a cuff position.Catheter 2620 pulls cuff 3100 and sleeve 3200 proximally up to thegastroesophageal junction or other cuff positions, some of which aredescribed elsewhere in the application.

FIG. 18H shows drawing a portion of a tissue wall into side port 2630 ofanchor delivery device 2620. A vacuum may be applied through the workinglumen of an endoscope placed in central lumen 2625.

FIG. 18I shows delivering tissue anchor 1300. Anchor delivery device2600 is used to deliver tissue anchors 1300 through cuff 3100 and thewall of the esophagus. Tissue anchor 1300A, tissue anchor 2300, tissueanchor 3300, tissue anchor 4300, and/or any other suitable tissue anchormay also be used. Tissue marks made earlier by tissue marking device1400 may be used as a guide.

FIG. 18J shows removing anchor delivery device 2600.

Alternatively, the method may include first deploying sleeve 3200without cuff 3100, then anchoring cuff 3100 at the cuff position, andthen grasping sleeve 3200 to attach sleeve 3200 to cuff 3100.

FIGS. 25A-25D show various embodiments of cuff positions which may beused with the devices and methods described above. Tissue anchors may bedelivered through a wall of the esophagus at a cuff position to retain agastrointestinal bypass device. Alternatively, or in combination, anintragastric support such as that found, for example, in U.S. Pat. No.8,182,441 to Swain et al. may be used. The size and relative locationsof the opening O of the stomach S, the squamocolumnar junction SCJ, thediaphragm D, and the lower esophageal sphincter LES may vary frompatient to patient, and one or more of these anatomical features may bereferenced separately or in combination to select a cuff position.

FIG. 25A shows one embodiment of a cuff position 1710. The esophagus Eand the opening O of the stomach S are shown. Cuff position 1710 may beapproximately 5 mm to approximately 25 mm above the opening O of thestomach S.

FIG. 25B shows another embodiment of a cuff position 1720. The esophagusE and the squamocolumnar junction SCJ, also known as the Z-line, areshown. Cuff position 1720 may be approximately 0 mm to approximately 20mm above the squamocolumnar junction SCJ.

FIG. 25C shows yet another embodiment of a cuff position 1730. Theesophagus E and the diaphragm D are shown. Cuff position 1730 may beapproximately 20 mm below to approximately 50 mm above the diaphragm D.The diaphragm D may be located using imaging techniques and/or othermethods before and/or during the delivery of the tissue anchors. Thediaphragm D may be located by locating the diaphragmatic pinch in theesophagus E.

FIG. 25D shows still another embodiment of a cuff position 1740. Theesophagus E and the lower esophageal sphincter LES are shown. Cuffposition 1740 may be at an upper or proximal portion of the loweresophageal sphincter LES.

FIGS. 19A-19F show one embodiment of a method for exchanging a sleeve2200. The method may also be used for exchanging a sleeve 3200. In someembodiments, anchor delivery device 2600 may be used to replace tissueanchors 1300, such as those that may have pulled out of tissue, withoutnecessarily requiring exchange of sleeve 3200 and/or cuff 3100.

FIG. 19A shows a cuff 2100 and a sleeve 2200 implanted in an esophagus.A grasping tool is introduced into the esophagus.

FIG. 19B shows removing sleeve 2200. The grasping tool passes throughcuff 2100 to grasp sleeve 2200. The grasping tool may be configured topull drawstring 2241 to cinch ring 2240 of sleeve 2200. Halo 2260 orattachment elements 3260 may be cut. Sleeve 2200 is pulled out.

FIG. 19C shows introducing sleeve delivery device 1500. Sleeve deliverydevice 1500 passes through cuff 2100 and may position sleeve 2200 at ornear the pylorus. Sleeve delivery device 1500 may be introduced with orwithout an overtube. Sleeve delivery device 2500 or sleeve deliverydevice 3500 may also be used. An endoscope may be used for guidance andvisualization.

FIG. 19D shows deploying sleeve 2200. A fluid is pumped into deliverydevice 1500 to evert sleeve 2200 past the pylorus and into theintestine.

FIG. 19E shows positioning sleeve 2200 in the stomach. Sleeve deliverydevice 1500 pulls sleeve 2200 into the stomach.

FIG. 19F shows releasing sleeve 2200 from sleeve delivery device 1500.Sleeve delivery device 1500 is then withdrawn.

FIG. 19G shows grasping sleeve 2200. A grasping tool may be passedthrough cuff 2100 to grasp sleeve 2200. The grasping tool may beconfigured to pull drawstring 2241 to cinch ring 2240 of sleeve 2200.

FIG. 19H shows attaching sleeve 2200 to cuff 2100. The grasping toolpulls ring 2240 of sleeve 2200 into cuff 2100 so that ring 2240 may becoupled to retainer 2140. Halo 2260 or attachment elements 3260 may becoupled to hooks 2160 or through attachment openings 3160, respectively.

While the foregoing has been with reference to particular embodiments ofthe invention, it will be appreciated by those skilled in the art thatchanges in these embodiments may be made without departing from theprinciples and spirit of the invention, including embodiments that donot provide all the features and benefits described herein. It will beunderstood by those skilled in the art that the present disclosureextends beyond the specifically disclosed embodiments to otheralternative or additional embodiments and/or uses and obviousmodifications and equivalents thereof. In addition, while a number ofvariations have been shown and described in varying detail, othermodifications, which are within the scope of the present disclosure,will be readily apparent to those of skill in the art based upon thisdisclosure. It is also contemplated that various combinations orsubcombinations of the specific features and aspects of the embodimentsmay be made and still fall within the scope of the present disclosure.Accordingly, it should be understood that various features and aspectsof the disclosed embodiments can be combined with or substituted for oneanother in order to form varying modes of the present disclosure. Thus,it is intended that the scope of the present disclosure herein disclosedshould not be limited by the particular disclosed embodiments describedabove. For all of the embodiments described above, the steps of anymethods need not be performed sequentially.

What is claimed is:
 1. A gastrointestinal bypass device, comprising: agastrointestinal cuff configured to be at least partially positioned inan esophagus; and a gastrointestinal sleeve coupled to the cuff, thesleeve configured to be at least partially positioned in a stomach and asmall intestine; wherein the cuff and the sleeve are configured to allowa bypassed portion of food to be bypassed past the stomach and into thesmall intestine, and wherein the cuff and/or the sleeve are configuredto allow a nonbypassed portion of food to pass into the stomach.
 2. Thedevice of claim 1, wherein the cuff includes a liner configured to allowthe nonbypassed portion of food to pass from an inside of the liner toan outside of the liner.
 3. The device of claim 2, wherein the liner isat least partially made of a woven material having openings.
 4. Thedevice of claim 2, wherein the liner is at least partially made of amesh material having openings.
 5. The device of claim 2, wherein theliner includes one or more, or any combination of, openings, slits,holes, channels, valves, and/or flaps.
 6. The device of claim 1, whereinthe cuff includes a liner configured to allow an amount of thenonbypassed portion of food to be adjusted in situ.
 7. The device ofclaim 6, wherein the liner includes one or more temporary or removableportions and/or layers.
 8. The device of claim 1, wherein the cuffincludes a liner having a proximal portion that allows the nonbypassedportion of food to pass into the stomach.
 9. The device of claim 8,wherein the proximal portion of the liner includes a scalloped edge. 10.The device of claim 9, wherein the scalloped edge includes a pluralityof peaks and valleys configured to allow the nonbypassed portion of foodto pass through the valleys to an outside of the liner and into thestomach.
 11. The device of claim 1, wherein the sleeve includes a tubeconfigured to allow the nonbypassed portion of food to pass from aninside of the tube to an outside of the tube.
 12. The device of claim11, wherein the tube includes one or more, or any combination of,openings, slits, holes, channels, valves, and/or flaps.
 13. The deviceof claim 1, wherein the sleeve includes a tube configured to allow anamount of the nonbypassed portion of food to be adjusted in situ. 14.The device of claim 13, wherein the tube includes one or more temporaryor removable portions and/or layers.
 15. A method of providingadjustable gastric bypass, the method comprising: positioning at least aportion of a gastrointestinal cuff in an esophagus; positioning at leasta portion of a gastrointestinal sleeve in a stomach and a smallintestine, wherein the cuff and the sleeve are configured to allow abypassed portion of food to be bypassed past the stomach and into thesmall intestine, and wherein the cuff and/or the sleeve are configuredto allow a nonbypassed portion of food to pass into the stomach; andadjusting an amount of the nonbypassed portion of food allowed to passinto the stomach.
 16. The method of claim 15, wherein the cuff includesa liner, and wherein adjusting an amount includes removing one or moretemporary or removable portions of the liner.
 17. The method of claim15, wherein the sleeve includes a tube, and wherein adjusting an amountincludes removing one or more temporary or removable portions of thetube.